Roche Diagnostics Corporation

Complete recall history across all FDA and CPSC categories — 39 total recalls

Roche Diagnostics Corporation appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (39)

FDA medical device enforcement actions by Roche Diagnostics Corporation

Date Product Reason Class
Jun 3, 2019 The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies... Calibration failures with Std.E, Sens.E, or Dup.E error due to atypical react... Class II
Apr 4, 2019 cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic s... There is a potential for the tray input flap on the post analytical units to ... Class III
Apr 4, 2019 cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic s... There is a potential for the tray input flap on the post analytical units to ... Class III
Mar 18, 2019 Albumin BCP Product Usage: ALBP is an in vitro test used for the quantit... The reagent lot is exhibiting calibration failures, QC imprecision, and eleva... Class II
Mar 15, 2019 cobas e 801 immunoassay analyzer The firm has confirmed complaints regarding signal drops on the cobas e 801 m... Class II
Feb 4, 2019 Cobas¿ infinity central lab IT solution Material Number: 07154003001 Ca... Using the following versions of cobas infinity software (2.0 thorough 2.5), t... Class II
Dec 17, 2018 Tina-quant IgM Gen.2, Catalog Nos. 03507190190, 05220726190, 03507041190, 035... New endogenous interference claims have been established for the following as... Class II
Dec 17, 2018 Anti-HAV IgM test System, Material No. 11820591160 Product Usage: The Roc... Potential for erroneous result messages for the Anti-HAV IgM assay when run o... Class II
Dec 17, 2018 Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795... New endogenous interference claims have been established for the following as... Class II
Dec 17, 2018 Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***add... New endogenous interference claims have been established for the following as... Class II
Dec 14, 2018 cobas c 111 with ISE analyzers analyzer used in the following assays: a)Crea... COBAS INTEGRA¿ 400 plus and cobas c 111 analyzers Additional Extra Wash Cycl... Class II
Dec 14, 2018 COBAS INTEGRA 400 plus analyzer used in the following assays: a)Tina-quant A... COBAS INTEGRA¿ 400 plus and cobas c 111 analyzers Additional Extra Wash Cycl... Class II
Sep 24, 2018 Roche Diagnostics URISYS 1100 Urine Analyzer Part Number: 03617556001 Pro... Limits of Detection (LoD) for protein, nitrite, leukocytes, and erythrocytes ... Class II
Sep 13, 2018 CoaguChek¿ XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips... Abnormally high INR test results with the affected CoaguChek test strips Class I
Jul 16, 2018 Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cob... Sample material may potentially come in contact with the pipetting nozzle dur... Class II
Apr 27, 2018 Elecsys Vitamin D total II, Vitamin D Test System, Material number 0702814819... The device may give a falsely elevated result that is non-reproducible. If vi... Class II
Apr 27, 2018 Elecsys Vitamin D total II, Vitamin D Test System, Material number 0746421516... The device may give a falsely elevated result that is non-reproducible. If vi... Class II
Apr 3, 2018 cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is ... The syringe plunger on the device may be mounted in a tilted position, which ... Class II
Feb 22, 2018 Cobas b 221<4>Roche OMNI S4 system; Catalog numbers: 3337138001 and 333713869... The software responsible for starting scheduled AutoQC measurements (schedule... Class II
Feb 22, 2018 cobas b 221<6>Roche OMNI S6 system; Catalog numbers: 3337154001 and 333715469... The software responsible for starting scheduled AutoQC measurements (schedule... Class II
Feb 22, 2018 cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692... The software responsible for starting scheduled AutoQC measurements (schedule... Class II
Feb 22, 2018 cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 331352269... The software responsible for starting scheduled AutoQC measurements (schedule... Class II
Jan 2, 2018 Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas... The previous version of method sheets for the Acetaminophen assay on the COBA... Class II
Dec 22, 2017 Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination... Product exhibits a decreased recovery of patient samples on the cobas e 801 m... Class II
Dec 18, 2017 Modular E 170 Analyzer: Immunoassay Chemistry Analyzer, Chemistry (Photometr... Complaints have been received concerning questionable results on analyzers du... Class II
Dec 18, 2017 cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for Clinical... Complaints have been received concerning questionable results on analyzers du... Class II
Dec 18, 2017 c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 mod... Complaints have been received concerning questionable results on analyzers du... Class II
Jul 28, 2017 Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 0564... A software failure may incorrectly set the system settings to "default" setti... Class II
Jul 18, 2017 cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 ... A warning is being added to the cobas¿ 6000 analyzer and the cobas¿ 8000 modu... Class II
Jul 18, 2017 cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 ... A warning is being added to the cobas¿ 6000 MODULAR Series System - c501 and ... Class II
Jul 5, 2017 Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/P... A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzer... Class II
Jul 5, 2017 cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775... A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzer... Class II
Jun 29, 2017 Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MOD... Roche has confirmed that a possible sample mismatch issue may occur on the MO... Class II
May 9, 2017 Cobas connection module (CCM) - OUTPUT UNIT The module CCM enables a unidire... a gap between the conveyor belt and the rack tray table (plastic part) may ca... Class II
Apr 10, 2017 Elecsys PreciControl Varia 3 e-barcode and value sheet for PreciControl Varia contains a typographical err... Class II
Mar 21, 2017 Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular ... Due to a design change in 2015, corrosion on the sample probe electrical cont... Class II
Mar 1, 2017 Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx Roche Diagnostics Corp. initiated a voluntary correction because a rack crash... Class II
Mar 1, 2017 Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx "Roche Diagnostics Corp. initiated a voluntary correction because a rack cras... Class II
Dec 27, 2016 cobas p 612 pre-analytical system; Pre-analytical sample handling that inc... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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