Roche Molecular Systems, Inc.
30 recalls on record · Latest: Feb 15, 2023
FDA Devices Moderate Feb 15, 2023
cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number 09446125190
FDA Devices Moderate Oct 26, 2022
cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory se…
FDA Devices Moderate Apr 6, 2022
cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
FDA Devices Moderate Oct 20, 2021
cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
FDA Devices Moderate Sep 29, 2021
cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
FDA Devices Moderate Apr 21, 2021
cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190
FDA Devices Moderate Apr 21, 2021
cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Liat System, Catalog Number: …
FDA Devices Moderate Jan 27, 2021
uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
FDA Devices Moderate Jan 20, 2021
The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and detection system for nucleic acids. Th…
FDA Devices Moderate Jul 22, 2020
MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541089001 - Product Usage: This protocol is intended for pipetting samples…
FDA Devices Moderate Jun 6, 2018
MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24 System is a fully automated clinical sample extractor. It extracts nucl…
FDA Devices Moderate Apr 4, 2018
Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.
FDA Devices Moderate Dec 21, 2016
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 the Zika v…
FDA Devices Moderate Jul 27, 2016
cobas¿ Liat¿ Analyzer
FDA Devices Moderate Jun 1, 2016
cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian Translation Instructions for Use
FDA Devices Low Jan 28, 2015
cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Intended for the identification of mutations in codons 12,13 and 61 of the KR…
FDA Devices Moderate May 29, 2013
cobas¿ 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.
FDA Devices Moderate Feb 6, 2013
COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE.
FDA Devices Moderate Jan 2, 2013
COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrument used with CAP/CA and CAP/CTM. Roch…
FDA Devices Moderate Dec 19, 2012
DataCare POC is an information management system that provides data management functionality for managing point-of -care testing data.
FDA Devices Moderate Dec 19, 2012
The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation of nucleic acids in various types of bi…
FDA Devices Moderate Dec 19, 2012
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), as well …
FDA Devices Moderate Dec 19, 2012
LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid…
FDA Devices Moderate Dec 19, 2012
The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler instrument for automated isolation of nucl…
FDA Devices Moderate Dec 19, 2012
DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS …
FDA Devices Moderate Dec 19, 2012
Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS¿ AmpliPrep instrument, COBAS¿ TaqMan¿ analy…
FDA Devices Low Nov 7, 2012
cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, Inc., Product Usage: The primary use of the cobas 4800 B…
FDA Devices Moderate Sep 26, 2012
Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be used with a Lab…
FDA Devices Moderate Aug 22, 2012
COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input S-tube barcode clips hold sample input tubes in the COBAS AmpliPre…
FDA Devices Low Aug 15, 2012