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Roche Molecular Systems, Inc.

52 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; recall (Z-1104-2023)Roche Molecular Systems, Inc.2023-02-07
cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6 recall (Z-1105-2023)Roche Molecular Systems, Inc.2023-02-07
cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on th recall (Z-1106-2023)Roche Molecular Systems, Inc.2023-02-07
cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain React recall (Z-0097-2023)Roche Molecular Systems, Inc.2022-10-17
cobas Liat Influenza A/B Quality Control Kit; For use with cobas Liat Influenza A/B Assay. recall (Z-2203-2016)Roche Molecular Systems, Inc.2016-07-13
Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various recall (Z-1578-2016)Roche Molecular Systems, Inc.2016-04-27
cobas Liat Analyzer, for in vitro diagnostic use. recall (Z-2543-2015)Roche Molecular Systems, Inc.2015-09-02
cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Intended for the iden recall (Z-0999-2015)Roche Molecular Systems, Inc.2015-06-26
cobas EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay recall (Z-1320-2015)Roche Molecular Systems, Inc.2015-03-25
cobas PCR Urine Kit 100 PKT IVD cobas PCR Female Swab Kit 100 PKT IVD cobas PCR media 100T recall (Z-1111-2014)Roche Molecular Systems, Inc.2014-02-26
KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System, Inc. 1080 US recall (Z-2173-2013)Roche Molecular Systems, Inc.2013-09-10
cobas 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation recall (Z-1346-2013)Roche Molecular Systems, Inc.2013-05-21
COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE. recall (Z-0762-2013)Roche Molecular Systems, Inc.2013-01-31
COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample pro recall (Z-0614-2013)Roche Molecular Systems, Inc.2012-12-23
Data Station AMPLILINK software is an instrument user interface/ data management software recall (Z-0484-2013)Roche Molecular Systems, Inc.2012-12-07
The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with t recall (Z-0485-2013)Roche Molecular Systems, Inc.2012-12-07
The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for aut recall (Z-0486-2013)Roche Molecular Systems, Inc.2012-12-07
LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection an recall (Z-0487-2013)Roche Molecular Systems, Inc.2012-12-07
LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time d recall (Z-0488-2013)Roche Molecular Systems, Inc.2012-12-07
The COBAS 8000 data manager modular analyzer series (all versions) is a is a fully automat recall (Z-0489-2013)Roche Molecular Systems, Inc.2012-12-07
The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, compute recall (Z-0490-2013)Roche Molecular Systems, Inc.2012-12-07
DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger C recall (Z-0491-2013)Roche Molecular Systems, Inc.2012-12-07
DataCara GM is an information management system that provides data management functionalit recall (Z-0492-2013)Roche Molecular Systems, Inc.2012-12-07
DataCare POC is an information management system that provides data management functionali recall (Z-0493-2013)Roche Molecular Systems, Inc.2012-12-07
cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, In recall (Z-0188-2013)Roche Molecular Systems, Inc.2012-11-02
Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS recall (Z-2403-2012)Roche Molecular Systems, Inc.2012-09-18
COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input S-tube recall (Z-2209-2012)Roche Molecular Systems, Inc.2012-08-15
Cobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage: The Cobas KRAS recall (Z-2159-2012)Roche Molecular Systems, Inc.2012-08-08
COBAS AmpliPrep / COBAS TaqMan HCV Test, US-IVD The COBAS AmpliPrep/COBAS TaqMan HCV Test recall (Z-2586-2011)Roche Molecular Systems, Inc.2011-06-17
COBAS AmpliPrep / COBAS TaqMan HCV Test, CE-IVD The COBAS AmpliPrep/COBAS TaqMan HCV Test recall (Z-2587-2011)Roche Molecular Systems, Inc.2011-06-17
Factor II (Prothrombin) G20210A Kit Light Cycler Instrument; Manufactured in Germany for R recall (Z-2565-2011)Roche Molecular Systems, Inc.2011-06-14
Factor V Leiden Kit Light Cycler Instrument; Manufactured in Germany for Roche Molecular S recall (Z-2566-2011)Roche Molecular Systems, Inc.2011-06-14
COBAS AmpliPrep/COBAS TaqMan HBV v2.0 US-IVD; COBAS AmpliPrep/COBAS TaqMan HBV v2.0 CE-IVD recall (Z-1459-2011)Roche Molecular Systems, Inc.2011-03-01
FACTOR II (PROTHROMBIN) G20210A Kit, LightCycler 2.0 Instrument. Material Number 03610195 recall (Z1006-2010)Roche Molecular Systems, Inc.2010-03-05
AMPLILINK Software, version 3.1.0 to 3.2.2 with COBAS AmpliPrep. Catalog number 0356338300 recall (Z-1928-2009)Roche Molecular Systems, Inc.2009-08-27
Amplilink Software versions 1.1, 1.3, 1.4, 2.41. COBAS Amplicor CTA & NGA Tests recall (Z-1106-2007)Roche Molecular Systems, Inc.2007-08-02
Amplilink Software Versions 1.1, 1.3, 1.4, 2.41 COBAS AmpliPrep/COBAS Amplicor HCV Test, v recall (Z-1107-2007)Roche Molecular Systems, Inc.2007-08-02
AmpliChip CYP450 Test-US IVD-M/N: 4591402190, Roche Molecular Diagnostics recall (Z-0734-2007)Roche Molecular Systems, Inc.2007-04-11
AmpliChip CYP450 Test, CE-IVD, M/N: 4381866190, Roche Molecular Systems, Inc. recall (Z-0735-2007)Roche Molecular Systems, Inc.2007-04-11
TaqMan HBV Analyte Specific Reagent, Material Number 3322092018, containing HBV Quantitati recall (Z-0983-05)Roche Molecular Systems Inc2005-07-13
Amplicor [3] AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG Conjugate.) Kit: Amplicor CT recall (Z-1360-04)Roche Molecular Systems Inc2004-08-19
Amplicor [3] AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG Conjugate.) Kit: Amplicor CT recall (Z-1361-04)Roche Molecular Systems Inc2004-08-19
Amplicor [3] AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG Conjugate.) Kit: Amplicor HC recall (Z-1362-04)Roche Molecular Systems Inc2004-08-19
Amplicor [3] AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG Conjugate.) Kit: Amplicor IC recall (Z-1363-04)Roche Molecular Systems Inc2004-08-19
Amplicor [3] AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG Conjugate. Kit: AmpliCap HCV recall (Z-1364-04)Roche Molecular Systems Inc2004-08-19
Amplicor [3] AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG Conjugate. Kit: AMPLICOR IC D recall (Z-1365-04)Roche Molecular Systems Inc2004-08-19
Amplicor [3] AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG Conjugate. Kit: AMPLICOR M. a recall (Z-1366-04)Roche Molecular Systems Inc2004-08-19
Amplicor [3] AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG Conjugate. Kit: AMPLICOR MTB recall (Z-1367-04)Roche Molecular Systems Inc2004-08-19
Amplicor [3] AV-HRP, Avidin-HRP Horseradish Peroxidase) BGG Conjugate. Kit: AMPLICOR NG De recall (Z-1368-04)Roche Molecular Systems Inc2004-08-19
COBAS TaqMan Analyzer recall (Z-1119-04)Roche Molecular Systems Inc2004-07-27
COBAS TaqMan 48 Analyzers. recall (Z-1120-04)Roche Molecular Systems Inc2004-07-27
COBAS TaqMan analyzer, Series 96; catalog number 8080216. recall (Z-0917-03)Roche Molecular Systems Inc2003-06-05

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Every clearance here is in the API, with alerts when new ones post.