Roche Diagnostics Corporation recalls

39 recalls on record · latest: June 3, 2019

Official U.S. recall history for Roche Diagnostics Corporation, compiled from official government records.

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Roche Diagnostics Corporation recalls The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies react with antigen in the sample to form…

June 3, 2019 · Medical device recalls Moderate risk Calibration failures with Std.E, Sens.E, or Dup.E error due to atypical reactio…

Roche Diagnostics Corporation recalls cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.

April 4, 2019 · Medical device recalls There is a potential for the tray input flap on the post analytical units to be…

Roche Diagnostics Corporation recalls cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic sample storage and retrieval.

April 4, 2019 · Medical device recalls There is a potential for the tray input flap on the post analytical units to be…

Roche Diagnostics Corporation recalls Albumin BCP Product Usage: ALBP is an in vitro test used for the quantitative determination of albumin in human serum a…

March 18, 2019 · Medical device recalls Moderate risk The reagent lot is exhibiting calibration failures, QC imprecision, and elevate…

Roche Diagnostics Corporation recalls cobas e 801 immunoassay analyzer

March 15, 2019 · Medical device recalls Moderate risk The firm has confirmed complaints regarding signal drops on the cobas e 801 mod…

Roche Diagnostics Corporation recalls Cobas¿ infinity central lab IT solution Material Number: 07154003001 Calculator/Data Processing Module, For Clinical Use

February 4, 2019 · Medical device recalls Moderate risk Using the following versions of cobas infinity software (2.0 thorough 2.5), the…

Anti-HAV IgM test System recalled over hepatitis A risk

December 17, 2018 · Medical device recalls Moderate risk Potential for erroneous result messages for the Anti-HAV IgM assay when run on…

Roche Diagnostics Corporation recalls Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***added as of 5/10/19*** 03183700190 Product Usage:…

December 17, 2018 · Medical device recalls Moderate risk New endogenous interference claims have been established for the following assa…

Roche Diagnostics Corporation recalls Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795338160, 05795346160 ***added as of 5/10/19…

December 17, 2018 · Medical device recalls Moderate risk New endogenous interference claims have been established for the following assa…

Roche Diagnostics Corporation recalls Tina-quant IgM Gen.2, Catalog Nos. 03507190190, 05220726190, 03507041190, 03507149190 Product Usage: Immunoturbidimetri…

December 17, 2018 · Medical device recalls Moderate risk New endogenous interference claims have been established for the following assa…

Roche Diagnostics Corporation recalls COBAS INTEGRA 400 plus analyzer used in the following assays: a)Tina-quant Apolipoprotein A-1 ver.2 Catalog Number: 030…

December 14, 2018 · Medical device recalls Moderate risk COBAS INTEGRA¿ 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle C…

Roche Diagnostics Corporation recalls cobas c 111 with ISE analyzers analyzer used in the following assays: a)Creatinine plus ver.2 Catalog Number: 054014701…

December 14, 2018 · Medical device recalls Moderate risk COBAS INTEGRA¿ 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle C…

Roche Diagnostics Corporation recalls Roche Diagnostics URISYS 1100 Urine Analyzer Part Number: 03617556001 Product Usage: The URISYS 1100 Urine Analyzer is…

September 24, 2018 · Medical device recalls Moderate risk Limits of Detection (LoD) for protein, nitrite, leukocytes, and erythrocytes on…

Roche Diagnostics Corporation recalls CoaguChek¿ XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160; CoaguChek XS…

September 13, 2018 · Medical device recalls High risk Abnormally high INR test results with the affected CoaguChek test strips

Roche Diagnostics Corporation recalls Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cobas p 612 pre-analytical system is a computer co…

July 16, 2018 · Medical device recalls Moderate risk Sample material may potentially come in contact with the pipetting nozzle durin…

Roche Diagnostics Corporation recalls Elecsys Vitamin D total II, Vitamin D Test System, Material number 07464215160 Product Usage: This assay is intended fo…

April 27, 2018 · Medical device recalls Moderate risk The device may give a falsely elevated result that is non-reproducible. If vita…

Roche Diagnostics Corporation recalls Elecsys Vitamin D total II, Vitamin D Test System, Material number 07028148190 Product Usage: This assay is intended fo…

April 27, 2018 · Medical device recalls Moderate risk The device may give a falsely elevated result that is non-reproducible. If vita…

Roche Diagnostics Corporation recalls cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyz…

April 3, 2018 · Medical device recalls Moderate risk The syringe plunger on the device may be mounted in a tilted position, which ap…

Roche Diagnostics Corporation recalls cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 3313522692 The Roche Diagnostics Omni S Analyzer is…

February 22, 2018 · Medical device recalls Moderate risk The software responsible for starting scheduled AutoQC measurements (scheduler)…

Roche Diagnostics Corporation recalls cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S Analyzer is…

February 22, 2018 · Medical device recalls Moderate risk The software responsible for starting scheduled AutoQC measurements (scheduler)…

Roche Diagnostics Corporation recalls cobas b 221<6>Roche OMNI S6 system; Catalog numbers: 3337154001 and 3337154692 The Roche Diagnostics Omni S Analyzer is…

February 22, 2018 · Medical device recalls Moderate risk The software responsible for starting scheduled AutoQC measurements (scheduler)…

Roche Diagnostics Corporation recalls Cobas b 221<4>Roche OMNI S4 system; Catalog numbers: 3337138001 and 3337138692 The Roche Diagnostics Omni S Analyzer is…

February 22, 2018 · Medical device recalls Moderate risk The software responsible for starting scheduled AutoQC measurements (scheduler)…

Roche Diagnostics Corporation recalls Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminophen150 test

January 2, 2018 · Medical device recalls Moderate risk The previous version of method sheets for the Acetaminophen assay on the COBAS…

Roche Diagnostics Corporation recalls Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and pl…

December 22, 2017 · Medical device recalls Moderate risk Product exhibits a decreased recovery of patient samples on the cobas e 801 mod…

Roche Diagnostics Corporation recalls c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 module: Immunoassay Analyzer, Catalog Numbers…

December 18, 2017 · Medical device recalls Moderate risk Complaints have been received concerning questionable results on analyzers due…

Roche Diagnostics Corporation recalls cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for Clinical use), Catalog Numbers: 04775201001 (rack s…

December 18, 2017 · Medical device recalls Moderate risk Complaints have been received concerning questionable results on analyzers due…

Roche Diagnostics Corporation recalls Modular E 170 Analyzer: Immunoassay Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use, Catalog Num…

December 18, 2017 · Medical device recalls Moderate risk Complaints have been received concerning questionable results on analyzers due…

Roche Diagnostics Corporation recalls Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001

July 28, 2017 · Medical device recalls Moderate risk A software failure may incorrectly set the system settings to "default" setting…

Roche Diagnostics Corporation recalls cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 +…

July 18, 2017 · Medical device recalls Moderate risk A warning is being added to the cobas¿ 6000 MODULAR Series System - c501 and th…

Roche Diagnostics Corporation recalls cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module

July 18, 2017 · Medical device recalls Moderate risk A warning is being added to the cobas¿ 6000 analyzer and the cobas¿ 8000 modula…

Roche Diagnostics Corporation recalls cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775279973 - cobas e 411 analyzer (disk system…

July 5, 2017 · Medical device recalls Moderate risk A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers…

Roche Diagnostics Corporation recalls Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 - Elec…

July 5, 2017 · Medical device recalls Moderate risk A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers…

Roche Diagnostics Corporation recalls Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi M…

June 29, 2017 · Medical device recalls Moderate risk Roche has confirmed that a possible sample mismatch issue may occur on the MODU…

Roche Diagnostics Corporation recalls Cobas connection module (CCM) - OUTPUT UNIT The module CCM enables a unidirectional connection of the pre-analytical sy…

May 9, 2017 · Medical device recalls Moderate risk a gap between the conveyor belt and the rack tray table (plastic part) may caus…

Roche Diagnostics Corporation recalls Elecsys PreciControl Varia 3

April 10, 2017 · Medical device recalls Moderate risk e-barcode and value sheet for PreciControl Varia contains a typographical error…

Roche Diagnostics Corporation recalls Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular Analyzer Series, cobas c 311 analyzer cobas…

March 21, 2017 · Medical device recalls Moderate risk Due to a design change in 2015, corrosion on the sample probe electrical contac…

Roche Diagnostics product recalled over injury risk

March 1, 2017 · Medical device recalls Moderate risk "Roche Diagnostics Corp. initiated a voluntary correction because a rack crash…

Roche Diagnostics product recalled over injury risk

March 1, 2017 · Medical device recalls Moderate risk Roche Diagnostics Corp. initiated a voluntary correction because a rack crash m…

Roche Diagnostics Corporation recalls cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of…

December 27, 2016 · Medical device recalls Moderate risk