Roche Molecular Systems, Inc.

Complete recall history across all FDA and CPSC categories — 42 total recalls

Roche Molecular Systems, Inc. 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 (42)

FDA medical device enforcement actions by Roche Molecular Systems, Inc.

Date Product Reason Class
Dec 21, 2022 cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/... The firm received customer complaints regarding false negative Influenza A (F... Class II
Dec 21, 2022 cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test ... The firm received customer complaints regarding false negative Influenza A (F... Class II
Dec 21, 2022 cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the... The firm received customer complaints regarding false negative Influenza A (F... Class II
Sep 8, 2022 cobas 5800 instrument, Material No. 08707464001. Used for automated Polymeras... Reported false positive and invalid results on the affected devices due to an... Class II
Nov 16, 2021 cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material... Roche has identified a small number of cobas Liat analyzer units that have co... Class II
Sep 3, 2021 cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog N... False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation ... Class II
Aug 4, 2021 cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catal... Customers have reported an increased number of false positive SARS-CoV-2 resu... Class II
Mar 25, 2021 cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coron... Invalid or false positive results for one or more targets (SARS-CoV-2/Influen... Class II
Mar 25, 2021 cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catal... Invalid or false positive results for one or more targets (SARS-CoV-2/Influen... Class II
Nov 23, 2020 uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871... When a user creates a measurement tool annotation in the uPath Enterprise sof... Class II
Nov 19, 2020 The cobas z 480 analyzer including dedicated software for IVD use is a plate-... Dirty Lens May Cause Invalid or False Positive Results Class II
Jun 3, 2020 MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541... When using Sample Transfer protocol version 3.0, the drop catcher is not acti... Class II
May 2, 2018 MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24... Cross-contamination of samples has been reported when running the existing pr... Class II
Oct 27, 2017 Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes.... The cobas MRSA/SA tests may have decreased performance compared to the analyt... Class II
Nov 16, 2016 LightMix¿ Zika rRT-PCR Test The LightMix¿ Zika rRT-PCR Test is a real-time R... The LightCycler¿ 480 algorithm used for the LightMix¿ Zika rRT-PCR Test, EUA ... Class II
May 17, 2016 cobas¿ Liat Influenza A/B Quality Control Kit; For use with cobas¿ Liat Inf... Kit labeled with the incorrect expiration date. Class III
May 9, 2016 cobas¿ Liat¿ Analyzer Device was released with default pcal/gain settings for photometers instead ... Class II
Apr 5, 2016 cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2: 07248563190 ... During internal studies using contrived plasma specimens, several mutations (... Class II
Mar 15, 2016 cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian ... An error was found within the Hungarian translations of the cobas¿ EGFR Mutat... Class II
Mar 3, 2016 Hand-Held Scanner USB IT3800 For sample identification and tracking when use... The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep inst... Class II
Jul 24, 2015 cobas Liat Analyzer, for in vitro diagnostic use. Due to a supplier issue, the incorrect green and amber LED components were us... Class II
Jan 13, 2015 cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA a... False positive results for Exon 20 insertion mutations are being detected wit... Class III
Dec 18, 2014 cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Inten... cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant C... Class III
Jan 6, 2014 cobas¿ PCR Urine Kit 100 PKT IVD cobas¿ PCR Female Swab Kit 100 PKT IVD cob... Numerous complaints have been filed that leaking cobas ¿ PCR media 4.3 mL IVD... Class II
Jul 25, 2013 KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System... During an internal investigation, a formulation error that occurred was ident... Class II
Apr 1, 2013 cobas¿ 4800 system z480 instrument. Integrates fully automated total nu... In rare instances, channel shifted results have been generated with cobas¿ 48... Class II
Nov 28, 2012 COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE. The COBAS TaqMan MTB Test Definition Files (TDF) v3.0, for both CE-IVD and JP... Class II
Oct 11, 2012 COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Auto... Certain COBAS AmpliPrep instruments using AMPILINK software v.3.3.4 had the s... Class II
Jul 31, 2012 cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecula... It was identified that BRAF controls dispositioned as "Internal Use Only" wer... Class III
Jul 16, 2012 DataCara GM is an information management system that provides data management... Roche Molecular Systems, Inc. has become aware of a device-associated diagnos... Class II
Jul 16, 2012 The COBAS 8000 data manager modular analyzer series (all versions) is a is a... Roche Molecular Systems, Inc. has become aware of a device-associated diagnos... Class II
Jul 16, 2012 The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully autom... Roche Molecular Systems, Inc. has become aware of a device-associated diagnos... Class II
Jul 16, 2012 Data Station AMPLILINK software is an instrument user interface/ data managem... Roche Molecular Systems, Inc. has become aware of a device-associated diagnos... Class II
Jul 16, 2012 DataInnovations (Instrument Manager) (version 8.04) interfaces middleware bet... Roche Molecular Systems, Inc. has become aware of a device-associated diagnos... Class II
Jul 16, 2012 The MagNA Pure LC (version 3.0) is a sample preparation instrument that can... Roche Molecular Systems, Inc. has become aware of a device-associated diagnos... Class II
Jul 16, 2012 LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer wit... Roche Molecular Systems, Inc. has become aware of a device-associated diagnos... Class II
Jul 16, 2012 LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time... Roche Molecular Systems, Inc. has become aware of a device-associated diagnos... Class II
Jul 16, 2012 The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation ins... Roche Molecular Systems, Inc. has become aware of a device-associated diagnos... Class II
Jul 16, 2012 DataCare POC  is an information management system that provides data managem... Roche Molecular Systems, Inc. has become aware of a device-associated diagnos... Class II
Apr 23, 2012 Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqM... When using a Laboratory Information system (LIS) with automated systems utili... Class II
Feb 24, 2012 Cobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage... During the real-time stability testing for the cobas KRAS Mutation Test on th... Class III
Feb 1, 2012 COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. ... Certain lots of COBAS AmpliPrep (CAP) S-tube Input (Box of 12 bags 12x24 S-tu... 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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