Roche Molecular Systems, Inc.
Branchburg, NJ
This page shows every FDA and USDA recall linked to Roche Molecular Systems, Inc.. 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.
42
Total Recalls
2012
First Recall
2023
Most Recent
cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Sy...
Feb 7, 2023
· Device
Open, Classified
cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 092...
Feb 7, 2023
· Device
Open, Classified
cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Ma...
Feb 7, 2023
· Device
Open, Classified
cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucl...
Oct 17, 2022
· Device
Terminated
cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
Nov 16, 2021
· Device
Open, Classified
cobas EGFR Mutation Test v2-Somatic gene mutation detection system
Catalog Number :07248563190
Sep 3, 2021
· Device
Open, Classified
cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
Aug 4, 2021
· Device
Terminated
cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on th...
Mar 25, 2021
· Device
Open, Classified
cobas Liat Analyzer: respiratory virus panel nucleic acid assay system
Catalog Number: 07341920190
Mar 25, 2021
· Device
Open, Classified
uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
Nov 23, 2020
· Device
Terminated
The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and...
Nov 19, 2020
· Device
Terminated
MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541089001 - Product Usage: This pro...
Jun 3, 2020
· Device
Terminated
MagNA Pure 24 System, GMMI: 07290519001
Product Usage:
The MagNA Pure 24 System is a fully automated clinica...
May 2, 2018
· Device
Terminated
Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.
Oct 27, 2017
· Device
Terminated
LightMix Zika rRT-PCR Test
The LightMix Zika rRT-PCR Test is a real-time RT-PCR test intended for the qualitat...
Nov 16, 2016
· Device
Terminated
cobas Liat Influenza A/B Quality Control Kit; For use with cobas Liat Influenza A/B Assay.
Jul 13, 2016
· Device
Terminated
cobas Liat Analyzer
May 9, 2016
· Device
Terminated
Hand-Held Scanner USB IT3800
For sample identification and tracking when used with various systems
Apr 27, 2016
· Device
Terminated
cobas EGFR Mutation Test V2
Materials number
CE-IVD: EGFR v2: 07248563190
cfDNA: 07247737190
Device Identifi...
Apr 5, 2016
· Device
Terminated
cobas EGFR Mutation Test, v2 and cobas cfDNA Sample
Preparation Hungarian Translation Instructions for Use
Mar 15, 2016
· Device
Terminated
cobas Liat Analyzer, for in vitro diagnostic use.
Sep 2, 2015
· Device
Terminated
cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190.
Intended for the identification of mutat...
Jun 26, 2015
· Device
Terminated
cobas EGFR Mutation Test
epidermal growth factor receptor (EGFR) gene DNA assay
Mar 25, 2015
· Device
Terminated
cobas PCR Urine Kit 100 PKT IVD
cobas PCR Female Swab Kit 100 PKT IVD
cobas PCR media 100T IVD
cobas PCR Femal...
Feb 26, 2014
· Device
Terminated
KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD
Roche Molecular System, Inc. 1080 US highway 202 South B...
Sep 10, 2013
· Device
Terminated
cobas 4800 system z480 instrument.
Integrates fully automated total nucleic acid isolation directly from se...
May 21, 2013
· Device
Terminated
COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE.
Jan 31, 2013
· Device
Terminated
COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5
Automated sample processing instrument...
Dec 23, 2012
· Device
Terminated
The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation...
Dec 7, 2012
· Device
Terminated
DataCara GM is an information management system that provides data management functionality for managing blood...
Dec 7, 2012
· Device
Terminated
Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS Ampl...
Dec 7, 2012
· Device
Terminated
DataCare POC is an information management system that provides data management functionality for managing poi...
Dec 7, 2012
· Device
Terminated
The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry anal...
Dec 7, 2012
· Device
Terminated
DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry /...
Dec 7, 2012
· Device
Terminated
The COBAS 8000 data manager modular analyzer series (all versions) is a is a fully automated, random-access,...
Dec 7, 2012
· Device
Terminated
The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler ins...
Dec 7, 2012
· Device
Terminated
LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time detection and/or quan...
Dec 7, 2012
· Device
Terminated
LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection and/or quantification...
Dec 7, 2012
· Device
Terminated
cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, Inc.,
Product Usage:...
Nov 2, 2012
· Device
Terminated
Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqM...
Sep 18, 2012
· Device
Terminated
COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input S-tube barcode clips hold s...
Aug 15, 2012
· Device
Terminated
Cobas KRAS Mutation Test for In Vitro Diagnostic Use
Product Usage: Usage:
The Cobas KRAS Mutation Test, for...
Aug 8, 2012
· Device
Terminated