Roche Molecular Systems recalls
Roche Molecular Systems appears in 42 official U.S. recall notices indexed by RecallRadar, most recently on 2023-02-15.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems
FDA Device · Class II · 2023-02-15 · Roche Molecular Systems - cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems
FDA Device · Class II · 2023-02-15 · Roche Molecular Systems - cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems
FDA Device · Class II · 2023-02-15 · Roche Molecular Systems - cobas 5800 instrument, Material No. 08707464001
FDA Device · Class II · 2022-10-26 · Roche Molecular Systems - cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
FDA Device · Class II · 2022-04-06 · Roche Molecular Systems - cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
FDA Device · Class II · 2021-10-20 · Roche Molecular Systems - cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
FDA Device · Class II · 2021-09-29 · Roche Molecular Systems - cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190
FDA Device · Class II · 2021-04-21 · Roche Molecular Systems - cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Liat System, Catalog…
FDA Device · Class II · 2021-04-21 · Roche Molecular Systems - uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
FDA Device · Class II · 2021-01-27 · Roche Molecular Systems - The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and detection system for nucleic…
FDA Device · Class II · 2021-01-20 · Roche Molecular Systems - MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541089001 - Product Usage: This protocol is intended for pipettin…
FDA Device · Class II · 2020-07-22 · Roche Molecular Systems - MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24 System is a fully automated clinical sample extractor
FDA Device · Class II · 2018-06-06 · Roche Molecular Systems - Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic
FDA Device · Class II · 2018-04-04 · Roche Molecular Systems - 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 from t…
FDA Device · Class II · 2016-12-21 · Roche Molecular Systems - cobas¿ Liat¿ Analyzer
FDA Device · Class II · 2016-07-27 · Roche Molecular Systems - cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2: 07248563190 cfDNA: 07247737190 Device Identifier: EGFR v2.0: 00875197005448 c…
FDA Device · Class II · 2016-07-27 · Roche Molecular Systems - cobas¿ Liat Influenza A/B Quality Control Kit
FDA Device · Class III · 2016-07-20 · Roche Molecular Systems - cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian Translation Instructions for Use
FDA Device · Class II · 2016-06-01 · Roche Molecular Systems - Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems
FDA Device · Class II · 2016-05-04 · Roche Molecular Systems - cobas Liat Analyzer, for in vitro diagnostic use
FDA Device · Class II · 2015-09-09 · Roche Molecular Systems - cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
FDA Device · Class III · 2015-04-01 · Roche Molecular Systems - cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test
FDA Device · Class III · 2015-01-28 · Roche Molecular Systems - cobas¿ PCR Urine Kit 100 PKT IVD cobas¿ PCR Female Swab Kit 100 PKT IVD cobas¿ PCR media 100T IVD cobas¿ PCR Female Swab Kit 100 PKT JPN-IV…
FDA Device · Class II · 2014-03-05 · Roche Molecular Systems - KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System, Inc. 1080 US highway 202 South Branchburg, NJ 08876 USA Roche…
FDA Device · Class II · 2013-09-18 · Roche Molecular Systems - cobas¿ 4800 system z480 instrument
FDA Device · Class II · 2013-05-29 · Roche Molecular Systems - COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE
FDA Device · Class II · 2013-02-06 · Roche Molecular Systems - COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrument used with CAP/CA and CAP/CTM.…
FDA Device · Class II · 2013-01-02 · Roche Molecular Systems - DataCare POC is an information management system that provides data management functionality for managing point-of -care testing data
FDA Device · Class II · 2012-12-19 · Roche Molecular Systems - DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data
FDA Device · Class II · 2012-12-19 · Roche Molecular Systems - The COBAS 8000 data manager modular analyzer series (all versions) is a is a fully automated, random-access, software- controlled system fo…
FDA Device · Class II · 2012-12-19 · Roche Molecular Systems - Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS¿ AmpliPrep instrument, COBAS¿ Taq…
FDA Device · Class II · 2012-12-19 · Roche Molecular Systems - The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer
FDA Device · Class II · 2012-12-19 · Roche Molecular Systems - The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler instrument for automated isolation…
FDA Device · Class II · 2012-12-19 · Roche Molecular Systems - LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid)…
FDA Device · Class II · 2012-12-19 · Roche Molecular Systems - The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation of nucleic acids in various type…
FDA Device · Class II · 2012-12-19 · Roche Molecular Systems - LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nu…
FDA Device · Class II · 2012-12-19 · Roche Molecular Systems - DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems…
FDA Device · Class II · 2012-12-19 · Roche Molecular Systems - cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, Inc., Product Usage: The primary use of the cobas 4…
FDA Device · Class III · 2012-11-07 · Roche Molecular Systems - Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan
FDA Device · Class II · 2012-09-26 · Roche Molecular Systems - COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001
FDA Device · Class II · 2012-08-22 · Roche Molecular Systems - Cobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage: The Cobas KRAS Mutation Test, for use with the Cobas 4800 System…
FDA Device · Class III · 2012-08-15 · Roche Molecular Systems