PlainRecalls

Roche Diagnostics Corporation

Compiled from official public sources by the editorial team.

39 recalls on record · Latest: Jul 24, 2019

Roche Diagnostics Corporation Recall Insight

Roche Diagnostics Corporation appears on 39 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.038% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Jul 24, 2019, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 39 entries, severity tagging shows 1 critical, 36 moderate, and 2 lower-severity recalls. Affected-unit counts are disclosed on 36 of 39 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (39). The date window on this page runs from Feb 1, 2017 to Jul 24, 2019.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Jul 24, 2019

The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies react with antigen in the sample to form an antigen/antibody complex wh…

FDA Devices Low Jul 10, 2019

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

FDA Devices Low Jul 10, 2019

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

FDA Devices Moderate May 29, 2019

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

FDA Devices Moderate May 8, 2019

cobas e 801 immunoassay analyzer

FDA Devices Moderate Apr 24, 2019

Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***added as of 5/10/19*** 03183700190 Product Usage: An In vitro diagnosti…

FDA Devices Moderate Apr 24, 2019

Albumin BCP Product Usage: ALBP is an in vitro test used for the quantitative determination of albumin in human serum and plasma on Roche/Hitach…

FDA Devices Moderate Apr 24, 2019

Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795338160, 05795346160 ***added as of 5/10/19***05795397190, 05795648190…

FDA Devices Moderate Apr 24, 2019

Tina-quant IgM Gen.2, Catalog Nos. 03507190190, 05220726190, 03507041190, 03507149190 Product Usage: Immunoturbidimetric assay for the quantitati…

FDA Devices Moderate Apr 17, 2019

COBAS INTEGRA 400 plus analyzer used in the following assays: a)Tina-quant Apolipoprotein A-1 ver.2 Catalog Number: 03032566122 b)Tina-quant Albu…

FDA Devices Moderate Apr 17, 2019

cobas c 111 with ISE analyzers analyzer used in the following assays: a)Creatinine plus ver.2 Catalog Number: 05401470190; b)Triglycerides Cat…

FDA Devices Moderate Feb 6, 2019

Anti-HAV IgM test System, Material No. 11820591160 Product Usage: The Roche Elecsys Anti-HAV IgM immunoassay is used for the in vitro qualitative…

FDA Devices Critical Nov 14, 2018

CoaguChek¿ XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160; CoaguChek XS PT Test 6 Strips, Catalog N…

FDA Devices Moderate Nov 7, 2018

Roche Diagnostics URISYS 1100 Urine Analyzer Part Number: 03617556001 Product Usage: The URISYS 1100 Urine Analyzer is a reflectance photometer …

FDA Devices Moderate Sep 5, 2018

Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cobas p 612 pre-analytical system is a computer controlled fully automatic …

FDA Devices Moderate Jul 18, 2018

Elecsys Vitamin D total II, Vitamin D Test System, Material number 07464215160 Product Usage: This assay is intended for the quantitative determi…

FDA Devices Moderate Jul 18, 2018

Elecsys Vitamin D total II, Vitamin D Test System, Material number 07028148190 Product Usage: This assay is intended for the quantitative determi…

FDA Devices Moderate Jun 20, 2018

cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro dete…

FDA Devices Moderate May 9, 2018

cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 3313522692 The Roche Diagnostics Omni S Analyzer is a fully automated critical…

FDA Devices Moderate May 9, 2018

cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S Analyzer is a fully automated critical…

FDA Devices Moderate May 9, 2018

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

FDA Devices Moderate May 9, 2018

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

FDA Devices Moderate May 2, 2018

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

FDA Devices Moderate Apr 11, 2018

Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 and K3 EDTA, Li-He…

FDA Devices Moderate Apr 4, 2018

c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 module: Immunoassay Analyzer, Catalog Numbers: 04745922001, 05036348001, 05…

FDA Devices Moderate Apr 4, 2018

cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for Clinical use), Catalog Numbers: 04775201001 (rack system), 04775279001 (disk sys…

FDA Devices Moderate Apr 4, 2018

Modular E 170 Analyzer: Immunoassay Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use, Catalog Numbers: 03739040692, 030231090…

FDA Devices Moderate Mar 14, 2018

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3…

FDA Devices Moderate Mar 14, 2018

cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module

FDA Devices Moderate Feb 28, 2018

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

FDA Devices Moderate Feb 7, 2018

cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775279973 - cobas e 411 analyzer (disk system) and 04775201001/04775201973 …

FDA Devices Moderate Feb 7, 2018

Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 - Elecsys 2010 analyzer (disk system…

FDA Devices Moderate Jan 24, 2018

Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combinat…

FDA Devices Moderate Jun 14, 2017

Cobas connection module (CCM) - OUTPUT UNIT The module CCM enables a unidirectional connection of the pre-analytical systems cobas p 612/ p 512 to a…

FDA Devices Moderate Jun 7, 2017

Elecsys PreciControl Varia 3

FDA Devices Moderate May 17, 2017

Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular Analyzer Series, cobas c 311 analyzer cobas c 501/502 cobas c 701/702…

FDA Devices Moderate Apr 19, 2017

Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx

FDA Devices Moderate Apr 19, 2017

Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx

FDA Devices Moderate Feb 1, 2017

cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of samples for analysis.

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Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.