Roche Molecular Systems, Inc.: 22 recalls on record

Recalls filed with 1 agency: FDA (22).

First recall on record: August 15, 2012. Most recent: April 21, 2021.

Risk classification: Class II: 20 · Class III: 2

Most recent recalls

DateAgencyProduct
April 21, 2021FDAcobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 0…Z-1414-2021
April 4, 2018FDANucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro d…Z-1195-2018
July 27, 2016FDAcobas¿ Liat¿ AnalyzerZ-2216-2016
March 5, 2014FDAcobas¿ PCR Urine Kit 100 PKT IVD cobas¿ PCR Female Swab Kit 100 PKT IVD cobas¿ PCR medi…Z-1111-2014
September 18, 2013FDAKIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System, Inc. 1080 …Z-2173-2013
May 29, 2013FDAcobas¿ 4800 system z480 instrument. Integrates fully automated total nucleic acid i…Z-1346-2013
February 6, 2013FDACOBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE.Z-0762-2013
January 2, 2013FDACOBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample…Z-0614-2013
December 19, 2012FDADataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger …Z-0491-2013
December 19, 2012FDAThe MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used wit…Z-0485-2013
December 19, 2012FDAThe COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, comput…Z-0490-2013
December 19, 2012FDAThe COBAS 8000 data manager modular analyzer series (all versions) is a is a fully autom…Z-0489-2013
December 19, 2012FDADataCare POC  is an information management system that provides data management function…Z-0493-2013
December 19, 2012FDAThe MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for…Z-0486-2013
December 19, 2012FDALightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time …Z-0488-2013
December 19, 2012FDAData Station AMPLILINK software is an instrument user interface/ data management software…Z-0484-2013
December 19, 2012FDADataCara GM is an information management system that provides data management functionali…Z-0492-2013
December 19, 2012FDALightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection a…Z-0487-2013
November 7, 2012FDAcobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, I…Z-0188-2013
September 26, 2012FDAAmplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS…Z-2403-2012
August 22, 2012FDACOBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input S-tube…Z-2209-2012
August 15, 2012FDACobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage: The Cobas…Z-2159-2012

Questions about this company

How many recalls does Roche Molecular Systems, Inc. have?
Recalert has 22 U.S. recalls on record for Roche Molecular Systems, Inc., published between August 15, 2012 and April 21, 2021.
What was the most recent Roche Molecular Systems, Inc. recall?
FDA recall Z-1414-2021, published April 21, 2021: cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190
Which agencies have handled Roche Molecular Systems, Inc. recalls?
Roche Molecular Systems, Inc. appears as the recalling firm in recalls from: FDA (22).

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