Randox Laboratories Ltd. recalls

79 recalls on record · latest: June 7, 2024

Official U.S. recall history for Randox Laboratories Ltd., compiled from official government records.

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Randox Laboratories Ltd. recalls RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated…

June 7, 2024 · Medical device recalls Moderate risk Cystatin C Reagent marketed without a 510 (k)

Randox Laboratories Ltd. recalls Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and…

April 5, 2024 · Medical device recalls Foam gasket on the Evidence MultiSTAT chip heater assembly may not perform as e…

Randox Laboratories Ltd. recalls Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38…

March 5, 2024 · Medical device recalls Moderate risk Randox Laboratories has identified that Inorganic Phosphate in Calibration Seru…

Randox Laboratories Ltd. recalls Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays tha…

March 1, 2024 · Medical device recalls Moderate risk The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691…

Randox Laboratories Ltd. recalls Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated an…

February 14, 2024 · Medical device recalls Moderate risk Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared…

Randox Laboratories Ltd. recalls Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567

January 31, 2024 · Medical device recalls Moderate risk Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bia…

Randox Laboratories Ltd. recalls Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426

January 31, 2024 · Medical device recalls Moderate risk Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bia…

Randox Laboratories Ltd. recalls RX Series Copper (Cu) Assay Ref. Number CU2340

November 29, 2023 · Medical device recalls Moderate risk Randox Laboratories have released an update to the Carryover Avoidance Technica…

Randox Laboratories Ltd. recalls Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351

November 20, 2023 · Medical device recalls Moderate risk Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37¿C method…

Randox Laboratories Ltd. recalls Calibration Serum Level 3 CAL2351

November 20, 2023 · Medical device recalls Moderate risk CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias…

Randox Laboratories Ltd. recalls Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level…

November 13, 2023 · Medical device recalls Moderate risk There have been transcription errors on the Instructions For Use (IFU) of the C…

Randox Laboratories Ltd. recalls SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to…

November 6, 2023 · Medical device recalls A decrease in the reactivity of HSV Type 1/2 lgM in the Serology ToRCH lgM Posi…

Randox Laboratories Ltd. recalls RANDOX Total Bilirubin.

October 11, 2023 · Medical device recalls Moderate risk Randox has had reports of elevated patient results using Plasma (lithium hepari…

Randox Laboratories Ltd. recalls RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000

September 6, 2023 · Medical device recalls Moderate risk RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Au…

Randox Laboratories Ltd. recalls RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000

September 6, 2023 · Medical device recalls Moderate risk RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Au…

Randox Laboratories Ltd. recalls RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)

September 6, 2023 · Medical device recalls Moderate risk RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Au…

Randox Laboratories Ltd. recalls RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040

September 6, 2023 · Medical device recalls Moderate risk RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Au…

Randox Laboratories Ltd. recalls RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (2) RX4041R (refurbished)

September 6, 2023 · Medical device recalls Moderate risk RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Au…

Randox Laboratories Ltd. recalls Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215

August 3, 2023 · Medical device recalls Moderate risk there has been a transcription error in the Instructions for Use (IFU) for the…

Randox Laboratories Ltd. recalls Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement…

July 19, 2023 · Medical device recalls Moderate risk As part of the firm's ongoing quality monitoring (see internal complaint # OCC7…

Randox Laboratories Ltd. recalls Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase, Calcium,…

June 21, 2023 · Medical device recalls Moderate risk (1) There is vial to vial variation resulting in some vials recovering positive…

Randox Laboratories Ltd. recalls Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)

June 13, 2023 · Medical device recalls Moderate risk Carryover from the Direct LDL-cholesterol assay on the Rx instruments may resul…

Randox Laboratories Ltd. recalls Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and re…

May 4, 2023 · Medical device recalls Delay in reporting results due to Quality Controls running high outside of rang…

Randox Laboratories Ltd. recalls Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accur…

May 4, 2023 · Medical device recalls Delay in reporting results due to Quality Controls running high outside of rang…

Randox Laboratories Ltd. recalls Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical c…

November 22, 2022 · Medical device recalls Moderate risk Concentration of Rheumatoid Factor has decreased in Specific Protein Control Le…

Randox Laboratories Ltd. recalls Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and imm…

November 22, 2022 · Medical device recalls Moderate risk Concentration of Rheumatoid Factor has decreased in Specific Protein Control Le…

Randox Laboratories Ltd. recalls Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical c…

November 22, 2022 · Medical device recalls Moderate risk Concentration of Rheumatoid Factor has decreased in Specific Protein Control Le…

Randox Laboratories Ltd. recalls IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834

November 1, 2022 · Medical device recalls Moderate risk Update to the carryover avoidance technical bulletin to detail that IgA and IgM…

Randox Laboratories Ltd. recalls IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma Catalog Number: IA3832

November 1, 2022 · Medical device recalls Moderate risk Update to the carryover avoidance technical bulletin to detail that IgA and IgM…

Randox Laboratories Ltd. recalls The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, Anti HTLV 1…

August 1, 2022 · Medical device recalls Moderate risk ***Update** :HBsAg analyte is also Non-Reactive on the Ortho Vitros analyser as…

Randox Laboratories Ltd. recalls Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH2…

June 22, 2022 · Medical device recalls Moderate risk Product fails to meet the performance claims quoted on the kit insert: Manual P…

Randox Laboratories Ltd. recalls Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD

June 9, 2022 · Medical device recalls A customer reported a problem with the reagent and calibrator. Randox Laborator…

Randox Laboratories Ltd. recalls Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD

June 9, 2022 · Medical device recalls A customer reported a problem with the reagent and calibrator. Randox Laborator…

Randox Laboratories Ltd. recalls CK MB Calibrator, Catalogue Number CK2393

March 25, 2022 · Medical device recalls Randox have realigned CK-MB Calibrator, CK2393, lot number 4410CK. Calibrating…

Randox Laboratories Ltd. recalls RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200

November 1, 2021 · Medical device recalls Moderate risk When calibrating using the standard provided in the kit, the change in absorban…

Randox Laboratories Ltd. recalls NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115

May 10, 2021 · Medical device recalls Moderate risk Standard packed within NEFA kit has been assigned incorrectly. Calibrating with…

Randox Laboratories Ltd. recalls Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R

April 28, 2021 · Medical device recalls Moderate risk An issue was identified where the software froze during processing of commands,…

Randox Laboratories Ltd. recalls Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351

March 29, 2021 · Medical device recalls Moderate risk Randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin of…

Randox Laboratories Ltd. recalls Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catal…

November 13, 2020 · Medical device recalls Moderate risk Failing to meet the linearity performance claims quoted on the kit inserts-The…

Randox Laboratories Ltd. recalls Randox Rx Series Mg - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urin…

November 13, 2020 · Medical device recalls Moderate risk Failing to meet the linearity performance claims quoted on the kit inserts-The…

Randox Laboratories Ltd. recalls Lactate Dehydrognease P-L, (UV), Catalog Number LD3818 - Product Usage: device intended for the quantitative in vitro d…

August 11, 2020 · Medical device recalls Moderate risk An update to the carryover avoidance technical bulletin to introduce additional…

Randox Laboratories Ltd. recalls Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device intended for the quantitative in…

August 11, 2020 · Medical device recalls Moderate risk An update to the carryover avoidance technical bulletin to introduce additional…

RANDOX LABORATORIES, LTD. recalls AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma

July 30, 2020 · Medical device recalls Moderate risk Randox Ammonia reagents are being recalled from the field due to a positive bia…

RANDOX LABORATORIES, LTD. recalls AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma

July 30, 2020 · Medical device recalls Moderate risk Randox Ammonia reagents are being recalled from the field due to a positive bia…

RANDOX LABORATORIES, LTD. recalls Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent

July 10, 2020 · Medical device recalls Moderate risk Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have fai…

RANDOX LABORATORIES, LTD. recalls Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked-pNPG7 Reagent

July 10, 2020 · Medical device recalls Moderate risk Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have fai…

RANDOX LABORATORIES, LTD. recalls Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test system is a device intended for th…

June 26, 2020 · Medical device recalls Moderate risk Randox have confirmed imprecision of quality control and patient samples when u…

RANDOX LABORATORIES, LTD. recalls Randox Lipase Assay: Lipase Colorimetric R1 Buffer - Product Usage: A Lipase test system is a device intended for the q…

June 26, 2020 · Medical device recalls Moderate risk Randox have confirmed imprecision of quality control and patient samples when u…

RANDOX LABORATORIES, LTD. recalls Randox Lipase Assay: Lipase Colorimetric Reagent - Product Usage: A Lipase test system is a device intended for the qua…

June 26, 2020 · Medical device recalls Moderate risk Randox have confirmed imprecision of quality control and patient samples when u…

Randox Laboratories Ltd. recalls Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro…

February 18, 2020 · Medical device recalls Moderate risk The control target and range value for Sodium using the ISE indirect method has…

Randox Laboratories Ltd. recalls Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml

December 13, 2019 · Medical device recalls A transcription error has occurred for the Randox Lipase colorimetric value in…

Randox Laboratories Ltd. recalls Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032 Product Usage: Liquid Protein C…

August 9, 2019 · Medical device recalls Moderate risk The assigned value for Rheumatoid Factor over recovers against the reference ma…

Randox Laboratories product recalled over hepatitis A risk

August 9, 2019 · Medical device recalls Moderate risk The assigned value for Rheumatoid Factor over recovers against the reference ma…

Randox Laboratories Ltd. recalls Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in…

July 25, 2019 · Medical device recalls Analyte range for Leukocytes for use with the Siemens Multistix method is incor…

Randox Laboratories Ltd. recalls This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox cal…

July 12, 2019 · Medical device recalls Randox Laboratories realigned RX Analyser Series calibration targets by 10% for…

Randox Laboratories Ltd. recalls G-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618 Product Usage: This product is intended for in vitr…

April 3, 2019 · Medical device recalls Moderate risk The target values and ranges in these lots are incorrect.

Randox Laboratories Ltd. recalls G-6-PDH Deficient Control (G-6-PDH CONTROL D), Catalogue Number PD2617 Product Usage: This product is intended for in v…

April 3, 2019 · Medical device recalls Moderate risk The target values and ranges in these lots are incorrect.

Randox Laboratories Ltd. recalls Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053

March 11, 2019 · Medical device recalls Moderate risk Customers may observe a decrease in recovered concentration with regards to NTp…

Randox Laboratories Ltd. recalls Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis This product…

February 13, 2019 · Medical device recalls Moderate risk An error in the assignment of the control range pH in Blood Gas Control

Randox Laboratories Ltd. recalls Liquid Immunoassay Premium Controls, Model Number LIA3105 Product Usage: This product is intended for in vitro diagnost…

February 7, 2019 · Medical device recalls The target value for uptake is incorrect on the value sheet for an analyzer. Th…

Randox Laboratories Ltd. recalls Immunoassay Premium Controls, Model Numbers IA2633 and IA2638 Product Usage: This product is intended for in vitro diag…

February 7, 2019 · Medical device recalls The target value for uptake is incorrect on the value sheet for an analyzer. Th…

Randox Laboratories Ltd. recalls Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product Usage: This product is intended for in vitro…

February 7, 2019 · Medical device recalls The target value for uptake is incorrect on the value sheet for an analyzer. Th…

Randox Laboratories Ltd. recalls Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml GTIN: 05055273200904

December 4, 2018 · Medical device recalls Moderate risk Update to the carryover avoidance technical bulletin to introduce additional st…

Randox Laboratories Ltd. recalls Randox CALCIUM (Ca) COLORIMETRIC METHOD RX DAYTONA PLUS Cat. No. CA 8309 R1, Arsenazo Reagent 4 x 20 ml GTIN: 050552732…

December 4, 2018 · Medical device recalls Moderate risk Update to the carryover avoidance technical bulletin to introduce additional st…

Randox Laboratories Ltd. recalls Fructosamine Control 3, FR2996 This product is intended for in vitro use in the calibration of the Randox Liquid Fructo…

December 3, 2018 · Medical device recalls Moderate risk The firm is conducting a Device Modification for Fructosamine Calibrator, Fruct…

Randox Laboratories Ltd. recalls Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox Liquid Fruct…

December 3, 2018 · Medical device recalls Moderate risk The firm is conducting a Device Modification for Fructosamine Calibrator, Fruct…

Randox Laboratories Ltd. recalls Fructosamine Control 1, FR2994 This product is intended for in vitro use in the calibration of the Randox Liquid Fructo…

December 3, 2018 · Medical device recalls Moderate risk The firm is conducting a Device Modification for Fructosamine Calibrator, Fruct…

Randox Laboratories Ltd. recalls SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-…

November 19, 2018 · Medical device recalls Moderate risk Calibrator value sheets have been modified for assigned value of Alpha-1-Acid-G…

Randox Laboratories Ltd. recalls Liquid Cardiac Control, CQ5053

October 2, 2018 · Medical device recalls Moderate risk Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 424…

Randox Laboratories Ltd. recalls Liquid Cardiac Control, CQ5052

October 2, 2018 · Medical device recalls Moderate risk Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 424…

Randox Laboratories Ltd. recalls Liquid Cardiac Control, CQ5051

October 2, 2018 · Medical device recalls Moderate risk Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 424…

Randox Laboratories Ltd. recalls Liquid Cardiac Control - Level 3, cat. no. CQ5053 Product Usage: This product is intended for in vitro diagnostic use,…

June 8, 2018 · Medical device recalls Moderate risk The device is not suitable for the control of the Troponin T assay due to unacc…

Randox Laboratories Ltd. recalls Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683

May 22, 2018 · Medical device recalls Moderate risk The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed…

Randox Laboratories Ltd. recalls Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat. no. PS2682

May 22, 2018 · Medical device recalls Moderate risk The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed…

Randox Laboratories Ltd. recalls Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3), Cat. no. PS2684

May 22, 2018 · Medical device recalls Moderate risk The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed…

Randox Laboratories Ltd. recalls Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284 Product Usage: Fo…

March 2, 2018 · Medical device recalls Moderate risk Randox has now released further steps to avoid contamination of the Lipase Assa…

Randox Laboratories Ltd. recalls Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX LABORATORIES LTD. , This product is suit…

June 7, 2017 · Medical device recalls Moderate risk Randox confirmed low calibration absorbance with HbA1c, Catalog Number HA3830,…

Randox Laboratories Ltd. recalls IgE Calibrator Series

September 7, 2016 · Medical device recalls Moderate risk According to the firm, the IgE Calibrator Series IE2492 (lot 387-392IE) value a…

Randox Laboratories Ltd. recalls Randox Lipase (Colorimetric) Product Usage: A lipase test system is a device intended to measure the activity of the en…

August 2, 2016 · Medical device recalls Moderate risk According to the firm carry over was observed when the Lipase test is run direc…