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Roche Molecular Systems, Inc. Recalls

27 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Roche Molecular Systems, Inc..

27Total Recalls
0Critical
173,400Units Affected
Dec 21, 2022Most Recent
All Recalls

Every Roche Molecular Systems, Inc. Recall

Sorted by most recent. Click any recall for full details.

27 recalls
High RiskFDA
Roche Molecular Systems, Inc.
cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number 09446125190
Medical Devices·9,948 affected·Dec 21, 2022
High RiskFDA
Roche Molecular Systems, Inc.
cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in l...
Medical Devices·179 affected·Sep 8, 2022
High RiskFDA
Roche Molecular Systems, Inc.
cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
Respiratory Devices·14 affected·Nov 16, 2021
High RiskFDA
Roche Molecular Systems, Inc.
cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
Medical Devices·507 affected·Sep 3, 2021
High RiskFDA
Roche Molecular Systems, Inc.
cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
Medical Devices·211 affected·Aug 4, 2021
High RiskFDA
Roche Molecular Systems, Inc.
cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190
Respiratory Devices·5,430 affected·Mar 25, 2021
High RiskFDA
Roche Molecular Systems, Inc.
cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Liat System, Cata...
Diagnostic Devices·143,823 affected·Mar 25, 2021
High RiskFDA
Roche Molecular Systems, Inc.
uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
Medical Devices·27 affected·Nov 23, 2020
High RiskFDA
Roche Molecular Systems, Inc.
The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and detection system for nucle...
Diagnostic Devices·597 affected·Nov 19, 2020
High RiskFDA
Roche Molecular Systems, Inc.
MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24 System is a fully automated clinical sample extractor. It e...
Medical Devices·163 affected·May 2, 2018
High RiskFDA
Roche Molecular Systems, Inc.
Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.
Diagnostic Devices·136 affected·Oct 27, 2017
High RiskFDA
Roche Molecular Systems, Inc.
LightMix¿ Zika rRT-PCR Test The LightMix¿ Zika rRT-PCR Test is a real-time RT-PCR test intended for the qualitative detection of RNA fro...
Diagnostic Devices·24 affected·Nov 16, 2016
High RiskFDA
Roche Molecular Systems, Inc.
cobas¿ Liat¿ Analyzer
Medical Devices·2 affected·May 9, 2016
High RiskFDA
Roche Molecular Systems, Inc.
cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian Translation Instructions for Use
Medical Devices·8 affected·Mar 15, 2016
High RiskFDA
Roche Molecular Systems, Inc.
cobas¿ 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.
Medical Devices·425 affected·Apr 1, 2013
High RiskFDA
Roche Molecular Systems, Inc.
COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE.
Diagnostic Devices·335 affected·Nov 28, 2012
RecallFDA
Roche Molecular Systems, Inc.
cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, Inc., Product Usage: The primary use of the ...
Diagnostic Devices·44 affected·Jul 31, 2012
High RiskFDA
Roche Molecular Systems, Inc.
DataCare POC  is an information management system that provides data management functionality for managing point-of -care testing data.
Medical Devices·126 affected·Jul 16, 2012
High RiskFDA
Roche Molecular Systems, Inc.
The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation of nucleic acids in various...
Diagnostic Devices·13 affected·Jul 16, 2012
High RiskFDA
Roche Molecular Systems, Inc.
LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic aci...
Diagnostic Devices·3,772 affected·Jul 16, 2012
High RiskFDA
Roche Molecular Systems, Inc.
LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (...
Medical Devices·1,213 affected·Jul 16, 2012
High RiskFDA
Roche Molecular Systems, Inc.
The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler instrument for automated isola...
Medical Devices·816 affected·Jul 16, 2012
High RiskFDA
Roche Molecular Systems, Inc.
DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument syst...
Medical Devices·1,015 affected·Jul 16, 2012
High RiskFDA
Roche Molecular Systems, Inc.
Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS¿ AmpliPrep instrument, COBAS¿ T...
Diagnostic Devices·884 affected·Jul 16, 2012
High RiskFDA
Roche Molecular Systems, Inc.
Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be use...
Medical Devices·1,292 affected·Apr 23, 2012
RecallFDA
Roche Molecular Systems, Inc.
Cobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage: The Cobas KRAS Mutation Test, for use with the Cobas 4800...
Diagnostic Devices·264 affected·Feb 24, 2012
High RiskFDA
Roche Molecular Systems, Inc.
COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input S-tube barcode clips hold sample input tubes in the CO...
Medical Devices·2,132 affected·Feb 1, 2012