Roche Diagnostics Corporation
Indianapolis, IN
This page shows every FDA and USDA recall linked to Roche Diagnostics Corporation. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
39
Total Recalls
2016
First Recall
2019
Most Recent
cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic sample storage and retrieval.
Jul 3, 2019
· Device
Terminated
cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.
Jul 3, 2019
· Device
Terminated
The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies react with antigen in the sample...
Jun 3, 2019
· Device
Terminated
Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190,
***added as of 5/10/19*** 03183700190
Pr...
Apr 13, 2019
· Device
Terminated
Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795338160, 05795346160
***added as...
Apr 13, 2019
· Device
Terminated
Tina-quant IgM Gen.2, Catalog Nos. 03507190190, 05220726190, 03507041190, 03507149190
Product Usage:
Immunotu...
Apr 13, 2019
· Device
Terminated
Albumin BCP
Product Usage: ALBP is an in vitro test used for the quantitative determination of albumin in h...
Mar 18, 2019
· Device
Terminated
cobas e 801 immunoassay analyzer
Mar 15, 2019
· Device
Terminated
Cobas infinity central lab IT solution
Material Number: 07154003001
Calculator/Data Processing Module, For...
Feb 4, 2019
· Device
Terminated
Anti-HAV IgM test System, Material No. 11820591160
Product Usage:
The Roche Elecsys Anti-HAV IgM immunoassay...
Dec 17, 2018
· Device
Terminated
cobas c 111 with ISE analyzers analyzer used in the following assays:
a)Creatinine plus ver.2
Catalog Number:...
Dec 14, 2018
· Device
Terminated
COBAS INTEGRA 400 plus analyzer used in the following assays:
a)Tina-quant Apolipoprotein A-1 ver.2
Catalog N...
Dec 14, 2018
· Device
Terminated
CoaguChek XS System Prothrombin time test:
CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160;
Coag...
Nov 2, 2018
· Device
Terminated
Roche Diagnostics URISYS 1100 Urine Analyzer
Part Number: 03617556001
Product Usage:
The URISYS 1100 Urine An...
Sep 24, 2018
· Device
Terminated
Roche cobas p 612 pre-analytical system (63x)
Model: 07563116001
The cobas p 612 pre-analytical system is a...
Jul 16, 2018
· Device
Terminated
cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692
The Roche Diagnostics Omni S A...
May 3, 2018
· Device
Terminated
Cobas b 221<4>Roche OMNI S4 system; Catalog numbers: 3337138001 and 3337138692
The Roche Diagnostics Omni S...
May 3, 2018
· Device
Terminated
cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 3313522692
The Roche Diagnostics Omni S A...
May 3, 2018
· Device
Terminated
cobas b 221<6>Roche OMNI S6 system; Catalog numbers: 3337154001 and 3337154692
The Roche Diagnostics Omni S...
May 3, 2018
· Device
Terminated
Elecsys Vitamin D total II, Vitamin D Test System, Material number 07464215160
Product Usage:
This assay is i...
Apr 27, 2018
· Device
Terminated
Elecsys Vitamin D total II, Vitamin D Test System, Material number 07028148190
Product Usage:
This assay is i...
Apr 27, 2018
· Device
Terminated
cobas e 801 immunoassay analyzer, cobas 8000 Modular Series
The device is a fully automated, software control...
Apr 3, 2018
· Device
Terminated
Brand Name:
cobas c 6000 MODULAR Series System e 601
cobas c 8000 MODULAR Series System - e 602
Roche / H...
Jan 16, 2018
· Device
Terminated
Roche Acetaminophen assay
03255379160-HAcetaminophen (P)
20767174160- cobas c Integra AAcetaminophen150 test
Jan 2, 2018
· Device
Terminated
Elecsys BRAHMS PCT
Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human se...
Dec 22, 2017
· Device
Terminated
Modular E 170 Analyzer: Immunoassay Chemistry Analyzer, Chemistry
(Photometric, Discrete) for clinical use, Ca...
Dec 18, 2017
· Device
Terminated
cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for
Clinical use), Catalog Numbers: 0477520100...
Dec 18, 2017
· Device
Terminated
c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 module: Immunoassay Analyzer, Catalo...
Dec 18, 2017
· Device
Terminated
Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
Jul 28, 2017
· Device
Terminated
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 60...
Jul 18, 2017
· Device
Terminated
cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module
Jul 18, 2017
· Device
Terminated
cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775279973 - cobas e 411 analyzer (di...
Jul 5, 2017
· Device
Terminated
Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/115682486...
Jul 5, 2017
· Device
Terminated
Elecsys PreciControl Varia 3
May 31, 2017
· Device
Terminated
Cobas connection module (CCM) - OUTPUT UNIT
The module CCM enables a unidirectional connection of the pre-anal...
May 9, 2017
· Device
Terminated
Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx
Mar 23, 2017
· Device
Terminated
Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx
Mar 23, 2017
· Device
Terminated
Sample probes associated with:
cobas 6000 Series System, cobas 8000 Modular Analyzer Series, cobas c 311 analy...
Mar 21, 2017
· Device
Terminated
cobas p 612 pre-analytical system;
Pre-analytical sample handling that includes de-capping, Aliquotting and s...
Jan 24, 2017
· Device
Terminated