Ortho-Clinical Diagnostics recalls

131 recalls on record · latest: February 27, 2024

Official U.S. recall history for Ortho-Clinical Diagnostics, compiled from official government records.

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Ortho-Clinical Diagnostics recalls VITROS Performance Verifier I

February 27, 2024 · Medical device recalls Moderate risk The issue was mismatched diluent lots assembled into VITRO Chemistry Products P…

Ortho-Clinical Diagnostics recalls VITROS Performance Verifier II

February 27, 2024 · Medical device recalls Moderate risk The issue was mismatched diluent lots assembled into VITRO Chemistry Products P…

ORTHO-CLINICAL DIAGNOSTICS recalls VITROS Immunodiagnostic Products Troponin I ES Reagent Pack

June 5, 2023 · Medical device recalls Moderate risk Reagent packs could potentially contain incorrect wells, which will generate in…

ORTHO-CLINICAL DIAGNOSTICS recalls VITROS Immunodiagnostic Products Troponin I ES Calibrators

June 5, 2023 · Medical device recalls Moderate risk Reagent packs could potentially contain incorrect wells, which will generate in…

Ortho-Clinical Diagnostics recalls VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20-…

May 8, 2023 · Medical device recalls Moderate risk Potential to cause biased results in the upper end of the reportable range for…

Ortho Clinical Diagnostics recalls VITROS XT7600 Integrated System, Product code 6844461

July 20, 2020 · Medical device recalls Moderate risk When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be…

Ortho Clinical Diagnostics recalls VITROS XT3400 Chemistry System, Product code 6844458

July 20, 2020 · Medical device recalls Moderate risk When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be…

Ortho Clinical Diagnostics recalls VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750033355 - Product Us…

July 17, 2020 · Medical device recalls Moderate risk The reagent bottles may be swapped within the reagent pack, which may lead to f…

Ortho Clinical Diagnostics recalls VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI 10758750033386 - Product Usage…

July 17, 2020 · Medical device recalls Moderate risk The reagent bottles may be swapped within the reagent pack, which may lead to f…

Ortho-Clinical Diagnostics recalls VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test withi…

July 13, 2020 · Medical device recalls Moderate risk Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc…

Ortho-Clinical Diagnostics recalls VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic quantitatively measure total bilirubin (TBIL…

July 13, 2020 · Medical device recalls Moderate risk Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc…

Ortho-Clinical Diagnostics recalls VITROS Chemistry Products BuBc Slides - in vitro diagnostic use only. VITROS Chemistry Products BuBc Slides quantitativ…

July 13, 2020 · Medical device recalls Moderate risk Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc…

Ortho Clinical Diagnostics recalls VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 1075875…

May 20, 2020 · Medical device recalls Moderate risk Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be in…

Ortho Clinical Diagnostics recalls VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product Code: 6802915 Unique Identifier:…

May 20, 2020 · Medical device recalls Moderate risk Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be in…

Ortho Clinical Diagnostics recalls VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product Code:6844461 Unique Identifier: 107587500316…

May 20, 2020 · Medical device recalls Moderate risk Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be in…

Ortho Clinical Diagnostics recalls VITROS 5600 Integrated System Software Versions 3.3.3 and below Product Code: 6802413 Unique Identifier: 10758750002740

May 20, 2020 · Medical device recalls Moderate risk Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be in…

Ortho Clinical Diagnostics recalls VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique Identifier: 10758750007103

May 20, 2020 · Medical device recalls Moderate risk Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be in…

Ortho-Clinical Diagnostics recalls VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # 10758750004577 - Product Usage: For in vit…

May 11, 2020 · Medical device recalls Moderate risk Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecis…

Ortho-Clinical Diagnostics recalls VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Product Code 1202670, UDI # 10758750008513 - Pro…

May 11, 2020 · Medical device recalls Moderate risk Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecis…

Ortho-Clinical Diagnostics recalls VITROS Chemistry Product Performance Verifier II, Product Code 8067324, UDI # 10758750004317 - Product Usage: For in vi…

May 11, 2020 · Medical device recalls Moderate risk Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecis…

Ortho-Clinical Diagnostics recalls VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/90 SLDS, Product Code 8112724, UDI # 10758750004393 - Prod…

May 11, 2020 · Medical device recalls Moderate risk Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecis…

Ortho-Clinical Diagnostics recalls VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90 slides, UDI Number 10758750004201 -…

April 1, 2020 · Medical device recalls Moderate risk The Spanish and Swedish language versions of the IFU state that the assay can b…

Ortho-Clinical Diagnostics recalls VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number 10758750004294…

April 1, 2020 · Medical device recalls Moderate risk The Spanish and Swedish language versions of the IFU state that the assay can b…

Ortho Clinical Diagnostics recalls VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468

March 10, 2020 · Medical device recalls The specified reagent packs exhibit an increase in the frequency of unsuccessfu…

Ortho-Clinical Diagnostics recalls VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain…

September 10, 2019 · Medical device recalls Moderate risk Users may experience intermittent slide dispense issues with some cartridges du…

Ortho-Clinical Diagnostics recalls VITROS chemistry Products K+ Slides, Catalog No. 8157596. MicroSlides which contain reagents in a dry, multi-layered fo…

September 10, 2019 · Medical device recalls Moderate risk Users may experience intermittent slide dispense issues with some cartridges du…

Ortho-Clinical Diagnostics recalls VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Urine CL-). MicroSlides which contain reagent…

September 10, 2019 · Medical device recalls Moderate risk Users may experience intermittent slide dispense issues with some cartridges du…

Ortho Clinical Diagnostics recalls VITROS 5600 Integrated System, clinical chemistry analyzer

July 8, 2019 · Medical device recalls Moderate risk Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System

Ortho Clinical Diagnostics recalls VITROS 250 Chemistry System, clinical chemistry analyzer

July 8, 2019 · Medical device recalls Moderate risk Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System

Ortho Clinical Diagnostics recalls VITROS 250 Chemistry System, clinical chemistry analyzer

July 8, 2019 · Medical device recalls Moderate risk Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System

Ortho Clinical Diagnostics recalls VITROS 5,1 FS Chemistry System, clinical chemistry analyzer

July 8, 2019 · Medical device recalls Moderate risk Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System

Ortho Clinical Diagnostics recalls VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer

July 8, 2019 · Medical device recalls Moderate risk Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System

Ortho Clinical Diagnostics recalls VITROS 5,1 FS Chemistry System, clinical chemistry analyzer

July 8, 2019 · Medical device recalls Moderate risk Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System

Ortho Clinical Diagnostics recalls VITROS 250AT Chemistry System, clinical chemistry analyzer

July 8, 2019 · Medical device recalls Moderate risk Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System

Ortho Clinical Diagnostics recalls VITROS 4600 Chemistry System, clinical chemistry analyzer

July 8, 2019 · Medical device recalls Moderate risk Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System

Ortho Clinical Diagnostics recalls VITROS 4600 Chemistry System, clinical chemistry analyzer

July 8, 2019 · Medical device recalls Moderate risk Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System

Ortho Clinical Diagnostics recalls VITROS 350 Chemistry System, clinical chemistry analyzer

July 8, 2019 · Medical device recalls Moderate risk Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System

Ortho Clinical Diagnostics recalls VITROS 5600 Integrated System, clinical chemistry analyzer

July 8, 2019 · Medical device recalls Moderate risk Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System

Ortho Clinical Diagnostics recalls VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer

July 8, 2019 · Medical device recalls Moderate risk Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System

Ortho-Clinical Diagnostics recalls VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chemistry Products GLU Slides quantitatively meas…

June 17, 2019 · Medical device recalls Moderate risk Potentially Biased Results using VITROS Chemistry Products GLU Slides

Ortho-Clinical Diagnostics recalls VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) Product Usage: Performs discrete clinical tes…

April 8, 2019 · Medical device recalls Moderate risk Potential negative drift in Creatine Kinase (CK) results when used on the VITRO…

Ortho-Clinical Diagnostics recalls VITROS 250 Chemistry System, Product Code 8132086, (UDI # 10758750004409) Product Usage: Performs discrete clinical tes…

April 8, 2019 · Medical device recalls Moderate risk Potential negative drift in Creatine Kinase (CK) results when used on the VITRO…

Ortho-Clinical Diagnostics recalls VITROS 250 Chemistry System Refurbished, Product Code 6801759, (UDI # 10758750001330) Product Usage: Performs discrete…

April 8, 2019 · Medical device recalls Moderate risk Potential negative drift in Creatine Kinase (CK) results when used on the VITRO…

Ortho-Clinical Diagnostics recalls VITROS 250AT Chemistry System, Product Code 1758143, (UDI # 10758750000036) Product Usage: Performs discrete clinical t…

April 8, 2019 · Medical device recalls Moderate risk Potential negative drift in Creatine Kinase (CK) results when used on the VITRO…

Ortho-Clinical Diagnostics recalls VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 6844461 Product Usage: INTENDED USE: For in vitro…

March 20, 2019 · Medical device recalls Moderate risk Potential for sample fluid to be dispensed to an incorrect position on the Micr…

Ortho-Clinical Diagnostics recalls VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usage: The VITROS XT 7600 Integrated…

March 11, 2019 · Medical device recalls Moderate risk One of the software algorithms used to detect sample dispense errors was inadve…

Ortho-Clinical Diagnostics recalls VITROS¿ 3600 Immunoassay System-Software V3.3.2 & below Product Code: 6802783 For use in the in vitro quantitative, sem…

February 20, 2019 · Medical device recalls Moderate risk Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITR…

Ortho-Clinical Diagnostics recalls VITROS¿ ECi/ECiQ Immunodiagnostic System Product Code: 1922814 For use in the in vitro quantitative, semi-quantitative,…

February 20, 2019 · Medical device recalls Moderate risk Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITR…

Ortho-Clinical Diagnostics recalls VITROS¿ 5600 Integrated System -Software V3.3.2 & below Product Code: 6802413 For use in the in vitro quantitative, sem…

February 20, 2019 · Medical device recalls Moderate risk Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITR…

Ortho-Clinical Diagnostics recalls VITROS¿ 5600 Integrated System Refurbished-Software V3.3.2 & below Product Code: 6802915 For use in the in vitro quanti…

February 20, 2019 · Medical device recalls Moderate risk Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITR…

Ortho-Clinical Diagnostics recalls VITROS ECi Immunodiagnostic System Refurbished Product Code: 6801059 For use in the in vitro quantitative, semi-quantit…

February 20, 2019 · Medical device recalls Moderate risk Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITR…

Ortho-Clinical Diagnostics recalls VITROS¿ XT 7600 Integrated System-Software V3.4.1 & below Product Code: 6844461 For use in the in vitro quantitative, s…

February 20, 2019 · Medical device recalls Moderate risk Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITR…

Ortho-Clinical Diagnostics recalls VITROS¿ 3600 Immunoassay System Refurbished-Software V3.3.2 & below Product Code: 6802914 For use in the in vitro quant…

February 20, 2019 · Medical device recalls Moderate risk Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITR…

Ortho-Clinical Diagnostics recalls VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use only. VITROS Na+ Slides quanti…

January 22, 2019 · Medical device recalls Moderate risk Imprecision in the affected lot may produce negatively or positively biased pat…

Ortho-Clinical Diagnostics recalls VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only. CATALOG #(s): 6801710 INTENDED USE: For…

December 11, 2018 · Medical device recalls Moderate risk Negative bias results when using VITROS VALP Reagent, GEN 25.

ORTHO-CLINICAL DIAGNOSTICS recalls VITROS NT-proBNP Reagent, Cat No. 6802156 Product Usage: For in vitro diagnostic use only. For the quantitative measure…

November 1, 2018 · Medical device recalls Moderate risk The firm is extending their previous July 2018 recall to include additional pro…

VITROS Anti-HBe Reagent Pack recalled over hepatitis A risk

November 1, 2018 · Medical device recalls Moderate risk The firm is extending their previous July 2018 recall to include additional pro…

VITROS HBeAg Reagent recalled over hepatitis A risk

November 1, 2018 · Medical device recalls Moderate risk The firm is extending their previous July 2018 recall to include additional pro…

Ortho-Clinical Diagnostics recalls VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measurement of a variety of an…

October 19, 2018 · Medical device recalls Moderate risk Software anomaly may incorrectly extend the on-analyzer stability time for a lo…

Ortho-Clinical Diagnostics recalls VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a varie…

October 19, 2018 · Medical device recalls Moderate risk Software anomaly may incorrectly extend the on-analyzer stability time for a lo…

Ortho-Clinical Diagnostics recalls VITROS 4600 Chemistry System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of an…

October 19, 2018 · Medical device recalls Moderate risk Software anomaly may incorrectly extend the on-analyzer stability time for a lo…

Ortho-Clinical Diagnostics recalls VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vitro quantitative, semi-quantitative, and quali…

October 19, 2018 · Medical device recalls Moderate risk Software anomaly may incorrectly extend the on-analyzer stability time for a lo…

Ortho-Clinical Diagnostics recalls VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LD…

October 8, 2018 · Medical device recalls Moderate risk VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results

Ortho-Clinical Diagnostics recalls VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489 For in vitro diagnostic use only…

August 28, 2018 · Medical device recalls Moderate risk The reagent pack exhibits the potential for an increased frequency of calibrati…

Ortho-Clinical Diagnostics recalls VITROS 5600 Integrated System- (Refurbished). For use in the in vitro quantitative, semi-quantitative, and qualitative…

August 15, 2018 · Medical device recalls Moderate risk Potential for the VITROS 5600 Integrated System to dispense an insufficient sam…

Ortho-Clinical Diagnostics recalls VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a…

August 15, 2018 · Medical device recalls Moderate risk Potential for the VITROS 5600 Integrated System to dispense an insufficient sam…

Ortho-Clinical Diagnostics recalls VITROS Chemistry Products Cl- Slides, Product Code 844 5207 Product Usage: For in vitro diagnostic use only. VITROS Che…

July 11, 2018 · Medical device recalls The slides do not meet the maximum allowable interference (MAI) claims for trig…

Ortho-Clinical Diagnostics recalls VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage For in vitro diagnostic use only. VITROS Chem…

July 11, 2018 · Medical device recalls The slides do not meet the maximum allowable interference (MAI) claims for trig…

Ortho-Clinical Diagnostics recalls VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usage: VITROS CREA Slides (Product Code 680 2584)…

July 11, 2018 · Medical device recalls The slides did not meet the current claims for Limit of Blank (LoB), Limit of D…

Ortho-Clinical Diagnostics recalls VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage: VITROS Cl Slides (Product Code 684 4471) - F…

July 11, 2018 · Medical device recalls The slides failed to meet current claims for Limit of Blank (LoB), Limit of Det…

Ortho-Clinical Diagnostics recalls VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic

May 9, 2018 · Medical device recalls Moderate risk There is a potential for imprecise results when using the slides. Increase in i…

Ortho-Clinical Diagnostics recalls VITROS Sodium Slides, Catalog # 837 9034

May 5, 2018 · Medical device recalls Moderate risk Potential for positively biased results

Ortho-Clinical Diagnostics recalls VITROS Chemistry Products DAT Performance Verifier IV in vitro diagnostic

September 22, 2017 · Medical device recalls Moderate risk This product is not meeting the current storage labeling for unopened VITROS DA…

Ortho-Clinical Diagnostics recalls VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic

September 22, 2017 · Medical device recalls Moderate risk This product is not meeting the current storage labeling for unopened VITROS DA…

Ortho-Clinical Diagnostics recalls VITROS Chemistry Products DAT Performance Verifier II in vitro diagnostic

September 22, 2017 · Medical device recalls Moderate risk This product is not meeting the current storage labeling for unopened VITROS DA…

Ortho-Clinical Diagnostics recalls VITROS Chemistry Products DAT Performance Verifier III in vitro diagnostic

September 22, 2017 · Medical device recalls Moderate risk This product is not meeting the current storage labeling for unopened VITROS DA…

Ortho-Clinical Diagnostics recalls VITROS Chemistry Products DAT Performance Verifier I in vitro diagnostic

September 22, 2017 · Medical device recalls Moderate risk This product is not meeting the current storage labeling for unopened VITROS DA…

Ortho-Clinical Diagnostics recalls VITROS Chemistry Products PHYT Slides, REF/CATALOG 829 8671, Rx ONLY, IVD; Ortho-Clinical Diagnostics, Inc. For in vitr…

June 12, 2017 · Medical device recalls Moderate risk The firm identified the potential for biased results to be generated when proce…

Ortho-Clinical Diagnostics recalls enGen Track System with TCAutomation Software Version 4.2

April 26, 2017 · Medical device recalls Moderate risk A software anomaly with TCA Software V4.2 may potentially cause a delay in repo…

Ortho-Clinical Diagnostics recalls enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions with the InOut Communication Inte…

March 8, 2017 · Medical device recalls Moderate risk Software anomaly; Thermo-Fisher Scientific initially discovered and Ortho-Clini…

ORTHO-CLINICAL DIAGNOSTICS recalls VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD --- Ortho-Clinical Diagnostics Penc…

March 7, 2017 · Medical device recalls Moderate risk Increased frequency of calibration failures for VITROS Immunodiagnostic Product…

Ortho-Clinical Diagnostics recalls VITROS Chemistry Products VANC Reagent, REF/Product Code 680 1709, Unique Identifier No. 10758750006731, Rx ONLY, IVD -…

February 21, 2017 · Medical device recalls Moderate risk Potential for biased results generated using the specific lots of VITROS VANC R…

Ortho-Clinical Diagnostics recalls VITROS Chemistry Products Li (Lithium) Slides, REF/Catalog Number/Product Code 1632660 (18 slide format, 90 slides per…

February 1, 2017 · Medical device recalls Moderate risk Intermittent imprecision in results generated using two specific lots of VITROS…

Ortho-Clinical Diagnostics recalls VITROS Chemistry Products FS Calibrator 1, REF 680 1873 12 x 3 mL, Rx ONLY, IVD; used in conjunction with VITROS Chemis…

January 5, 2017 · Medical device recalls The company received a customer complaint for the inability to calibrate VITROS…

Ortho-Clinical Diagnostics recalls VITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodi…

December 20, 2016 · Medical device recalls Moderate risk There is a potential for biased results to be generated over the 10 day on-anal…

Ortho-Clinical Diagnostics recalls VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative measurement of total protein con…

December 8, 2016 · Medical device recalls Moderate risk There is a potential for variable negatively and positively biased urine protei…

Ortho-Clinical Diagnostics recalls VITROS CRP Slides: 1) VITROS¿ Chemistry Products CRP Slides (250 slides per sales unit), Catalog # 1926740 and 2) , VIT…

October 26, 2016 · Medical device recalls CRP samples diluted using VITROS Chemistry Products Specialty Diluent, VITROS C…

ORTHO-CLINICAL DIAGNOSTICS recalls VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN 10758750006287 / Product Code 6802892 - Reagent Pack,…

October 5, 2016 · Medical device recalls Moderate risk The device defect is a positive bias of up to 20% relative to the currently mar…

Ortho-Clinical Diagnostics recalls enGen Laboratory Automation System (Product Code ENGEN) configured with Thermo Scientific Centrifuge Module and TCAutom…

September 7, 2016 · Medical device recalls Moderate risk Ortho confirmed that it is possible for the mis-association of sample identific…

Ortho-Clinical Diagnostics recalls VITROS Chemistry Products TRIG Slides, REF/Product Codes 133 6544 (300 slides per sales unit) and 832 9930 (90 slides p…

August 11, 2016 · Medical device recalls Moderate risk Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used f…

Ortho-Clinical Diagnostics recalls VITROS Chemistry Products GLU Slides, REF/Product Code 170 7801 (300 slides per sales unit), Unique Device Identifier N…

August 11, 2016 · Medical device recalls Moderate risk Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used f…

Ortho-Clinical Diagnostics recalls VITROS Chemistry Products LAC Slides, REF/Product Codes 843 3880 (300 slides per sales unit) and 815 0112 (90 slides pe…

August 11, 2016 · Medical device recalls Moderate risk Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used f…

Ortho-Clinical Diagnostics recalls VITROS Chemistry Products URIC Slides, REF/Product Code 194 3927 (300 slides per sales unit), Unique Device Identifier…

August 11, 2016 · Medical device recalls Moderate risk Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used f…

ORTHO-CLINICAL DIAGNOSTICS recalls VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 2997, Unique Device Identifier N…

July 28, 2016 · Medical device recalls A field correction was issued by the firm for VITROS TSH reagent lot 5040 due t…

ORTHO-CLINICAL DIAGNOSTICS recalls VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identifier No. 10758750005017, REF/Catalog Numbe…

July 14, 2016 · Medical device recalls Moderate risk Ortho Clinical Diagnostics has issued a recall of their VITROS immunodiagnostic…

VITROS Immunodiagnostic Products HBsAg Controls recalled over hepatitis A risk

June 22, 2016 · Medical device recalls The signal/cutoff (s/c) results may increase throughout the open-reconstituted…

ORTHO-CLINICAL DIAGNOSTICS recalls VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code 874 4468, Unique Identifier No. 10758750005147…

June 2, 2016 · Medical device recalls Moderate risk Ortho-Clinical Diagnostics confirmed that sample results generated from VITROS…

Ortho-Clinical Diagnostics recalls VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used in conjunction with VITROS Chemistry Produ…

May 24, 2016 · Medical device recalls Ortho Clinical Diagnostics started receiving customer complaints for biased res…

Ortho-Clinical Diagnostics recalls VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 0261, Unique Device Identifier No. 10758750009114 or…

May 18, 2016 · Medical device recalls Moderate risk Ortho Clinical Diagnostics (OCD) confirmed a potential for biased calcium (Ca)…

Ortho-Clinical Diagnostics recalls enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 and Above and enGen Custom 2…

May 16, 2016 · Medical device recalls If the user selects the Comment or Interpretation option (in the enGEN .gsb fil…