Roche Molecular Systems, Inc. recalls

23 recalls on record · latest: December 21, 2022

Official U.S. recall history for Roche Molecular Systems, Inc., compiled from official government records.

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Roche Molecular Systems, Inc. recalls cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Nu…

December 21, 2022 · Medical device recalls Moderate risk The firm received customer complaints regarding false negative Influenza A (Flu…

Roche Molecular Systems, Inc. recalls cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems; Ma…

December 21, 2022 · Medical device recalls Moderate risk The firm received customer complaints regarding false negative Influenza A (Flu…

Roche Molecular Systems, Inc. recalls cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190

December 21, 2022 · Medical device recalls Moderate risk The firm received customer complaints regarding false negative Influenza A (Flu…

Roche Molecular Systems, Inc. recalls cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid…

September 8, 2022 · Medical device recalls Moderate risk Reported false positive and invalid results on the affected devices due to anom…

Roche Molecular Systems, Inc. recalls cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190

November 16, 2021 · Medical device recalls Moderate risk Roche has identified a small number of cobas Liat analyzer units that have cons…

Roche Molecular Systems, Inc. recalls cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190

September 3, 2021 · Medical device recalls Moderate risk False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation wh…

Roche Molecular Systems, Inc. recalls cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190

August 4, 2021 · Medical device recalls Moderate risk Customers have reported an increased number of false positive SARS-CoV-2 result…

Roche Molecular Systems, Inc. recalls cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190

March 25, 2021 · Medical device recalls Moderate risk Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza…

Roche Molecular Systems, Inc. recalls cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas L…

March 25, 2021 · Medical device recalls Moderate risk Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza…

Roche Molecular Systems, Inc. recalls uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001

November 23, 2020 · Medical device recalls Moderate risk When a user creates a measurement tool annotation in the uPath Enterprise softw…

Roche Molecular Systems, Inc. recalls The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and detectio…

November 19, 2020 · Medical device recalls Moderate risk Dirty Lens May Cause Invalid or False Positive Results

Roche Molecular Systems, Inc. recalls MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541089001 - Product Usage: This protocol is i…

June 3, 2020 · Medical device recalls Moderate risk When using Sample Transfer protocol version 3.0, the drop catcher is not activa…

Roche Molecular Systems, Inc. recalls MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24 System is a fully automated clinical sample ex…

May 2, 2018 · Medical device recalls Moderate risk Cross-contamination of samples has been reported when running the existing prot…

Roche Molecular Systems, Inc. recalls Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.

October 27, 2017 · Medical device recalls Moderate risk The cobas MRSA/SA tests may have decreased performance compared to the analytic…

Roche Molecular Systems, Inc. recalls LightMix¿ Zika rRT-PCR Test The LightMix¿ Zika rRT-PCR Test is a real-time RT-PCR test intended for the qualitative det…

November 16, 2016 · Medical device recalls Moderate risk The LightCycler¿ 480 algorithm used for the LightMix¿ Zika rRT-PCR Test, EUA (c…

Roche Molecular Systems, Inc. recalls cobas¿ Liat Influenza A/B Quality Control Kit; For use with cobas¿ Liat Influenza A/B Assay.

May 17, 2016 · Medical device recalls Kit labeled with the incorrect expiration date.

Roche Molecular Systems, Inc. recalls cobas¿ Liat¿ Analyzer

May 9, 2016 · Medical device recalls Moderate risk Device was released with default pcal/gain settings for photometers instead of…

Roche Molecular Systems, Inc. recalls cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2: 07248563190 cfDNA: 07247737190 Device Identifier: EGFR v2…

April 5, 2016 · Medical device recalls Moderate risk During internal studies using contrived plasma specimens, several mutations (L8…

Roche Molecular Systems, Inc. recalls cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian Translation Instructions for Use

March 15, 2016 · Medical device recalls Moderate risk An error was found within the Hungarian translations of the cobas¿ EGFR Mutatio…

Roche Molecular Systems, Inc. recalls Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems

March 3, 2016 · Medical device recalls Moderate risk The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instru…

Roche Molecular Systems, Inc. recalls cobas Liat Analyzer, for in vitro diagnostic use.

July 24, 2015 · Medical device recalls Moderate risk Due to a supplier issue, the incorrect green and amber LED components were used…

Roche Molecular Systems, Inc. recalls cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay

January 13, 2015 · Medical device recalls False positive results for Exon 20 insertion mutations are being detected with…

Roche Molecular Systems, Inc. recalls cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Intended for the identification of mutations in co…

December 18, 2014 · Medical device recalls cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Con…