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Roche Molecular Systems Recalls
42 recalls on record · August 15, 2012 to February 15, 2023 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 15, 2023Medical DevicesFDA
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; Mat
Hazard: The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to additional testing, psychological distress, and delays to targeted therapy for influenza as well as true diagnosis.
February 15, 2023Medical DevicesFDA
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 Num
Hazard: The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to additional testing, psychological distress, and delays to targeted therapy for influenza as well as true diagnosis.
February 15, 2023Medical DevicesFDA
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
Hazard: The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to additional testing, psychological distress, and delays to targeted therapy for influenza as well as true diagnosis.
October 26, 2022Medical DevicesFDA
Roche Molecular Systems, Inc. recalls cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid T
Hazard: Reported false positive and invalid results on the affected devices due to anomalous baselines. This may lead to erroneous or delayed diagnoses.
April 6, 2022Medical DevicesFDA
Roche Molecular Systems, Inc. recalls cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
Hazard: Roche has identified a small number of cobas Liat analyzer units that have consistently high noise levels (background signal) originating from the amber detector (used for Influenza B detection). This noise increases the probability of false positive Influenza B results.
October 20, 2021Medical DevicesFDA
Roche Molecular Systems, Inc. recalls cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
Hazard: False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment
September 29, 2021Medical DevicesFDA
Roche Molecular Systems, Inc. recalls cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
Hazard: Customers have reported an increased number of false positive SARS-CoV-2 results.
April 21, 2021Medical DevicesFDA
Roche Molecular Systems, Inc. recalls cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190
Hazard: Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) using the cobas SARS-CoV-2 & Influenza A/B assay for use under emergency use authorization on the cobas Liat analyzer, showed abnormal PCR growth curves
April 21, 2021Medical DevicesFDA
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 Li
Hazard: Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) using the cobas SARS-CoV-2 & Influenza A/B assay for use under emergency use authorization on the cobas Liat analyzer, showed abnormal PCR growth curves
January 27, 2021Medical DevicesFDA
Roche Molecular Systems, Inc. recalls uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
Hazard: When a user creates a measurement tool annotation in the uPath Enterprise software version 1.1, the measurement value is incorrectly calculated when the measurement is viewed in "Split View" viewing mode and the slides within the case are scanned at different magnifications.
January 20, 2021Medical DevicesFDA
Roche Molecular Systems, Inc. recalls The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and detection
Hazard: Dirty Lens May Cause Invalid or False Positive Results
July 22, 2020Medical DevicesFDA
Roche Molecular Systems, Inc. recalls MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541089001 - Product Usage: This protocol is i
Hazard: When using Sample Transfer protocol version 3.0, the drop catcher is not activated on the MagNA Pure 96 instrument, which introduces a potential risk for cross-contamination leading to erroneous results.
June 6, 2018Medical DevicesFDA
Roche Molecular Systems, Inc. recalls MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24 System is a fully automated clinical sampl
Hazard: Cross-contamination of samples has been reported when running the existing protocol on the system with the rack-based purification run.
April 4, 2018Medical DevicesFDA
Roche Molecular Systems, Inc. recalls Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.
Hazard: The cobas MRSA/SA tests may have decreased performance compared to the analytical sensitivity for MSRA detection. A screening failure can lead to potential infection in the colonized patient being tested as well as the spread of MSRA to others. The United States is not impacted, as the cobas MRSA/SA nucleic acid test for use on the cobas liat system is not available in the US.
December 21, 2016Medical DevicesFDA
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
Hazard: The LightCycler¿ 480 algorithm used for the LightMix¿ Zika rRT-PCR Test, EUA (catalog number 07987897001) occasionally (~1% of the time) calls a positive result for a negative sample if there is an inflection point in the fluorescence signal.
July 27, 2016Medical DevicesFDA
Roche Molecular Systems, Inc. recalls cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2: 07248563190 cfDNA: 07247737190 Device Identifier:
Hazard: During internal studies using contrived plasma specimens, several mutations (L8568R, Exon 19 deletion, T790M) inconsistently generated "No Mutation Detected" (ie False Negative ) result with the cobas EGFR mutation Text V2.0 when utilizing the cobas cfDNA Sample Preparation kit.
July 27, 2016Medical DevicesFDA
Roche Molecular Systems, Inc. recalls cobas¿ Liat¿ Analyzer
Hazard: Device was released with default pcal/gain settings for photometers instead of the pcal/gain settings that are required for release. The default settings can potentially lead to the generation of erroneous or invalid results.
July 20, 2016Medical DevicesFDA
Roche Molecular Systems, Inc. recalls cobas¿ Liat Influenza A/B Quality Control Kit; For use with cobas¿ Liat Influenza A/B Assay.
Hazard: Kit labeled with the incorrect expiration date.
June 1, 2016Medical DevicesFDA
Roche Molecular Systems, Inc. recalls cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian Translation Instructions for Use
Hazard: An error was found within the Hungarian translations of the cobas¿ EGFR Mutation Test v2 Instructions for Use (M/N 07340761001-01HU, Doc Rev. 1.0, Dated 08/2015) and the cobas¿ cfDNA Sample Preparation Kit Instructions for Use (M/N 07573758001-01HU, Doc. Rev. 1.0, Dated 05/2015).
May 4, 2016Medical DevicesFDA
Roche Molecular Systems, Inc. recalls Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems
Hazard: The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identified a sample barcode ID.
September 9, 2015Medical DevicesFDA
Roche Molecular Systems, Inc. recalls cobas Liat Analyzer, for in vitro diagnostic use.
Hazard: Due to a supplier issue, the incorrect green and amber LED components were used in the manufacture of the LED printed circuit board assemblies (PCBA) in certain cobas Liat Analyzers.
April 1, 2015Medical DevicesFDA
Roche Molecular Systems, Inc. recalls cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
Hazard: False positive results for Exon 20 insertion mutations are being detected with the cobas¿ EGFR Mutation Test, kit batch T08661.
January 28, 2015Medical DevicesFDA
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
Hazard: cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS Calibrator.
March 5, 2014Medical DevicesFDA
Roche Molecular Systems, Inc. recalls cobas¿ PCR Urine Kit 100 PKT IVD cobas¿ PCR Female Swab Kit 100 PKT IVD cobas¿ PCR media 100T IVD cobas¿ PCR Female S
Hazard: Numerous complaints have been filed that leaking cobas ¿ PCR media 4.3 mL IVD have been received from different lots of the cobas ¿ PCR Urine kits, cobas ¿ PCR Female Swab kits, and cobas ¿ PCR media kits.
September 18, 2013Medical DevicesFDA
Roche Molecular Systems, Inc. recalls KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System, Inc. 1080 US highway 202 South Branchburg
Hazard: During an internal investigation, a formulation error that occurred was identified during the manufacture of the cobas¿ 4800 HPV Master Mix reagent that was packaged in four (4) cobas¿ 4800 AMP/DET kits, US- and CE-IVD (240 and 960 test kit configurations). Examination of the batch production record of the material revealed there was an error in the tare weight used for the carboy during the fina
May 29, 2013Medical DevicesFDA
Roche Molecular Systems, Inc. recalls cobas¿ 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondar
Hazard: In rare instances, channel shifted results have been generated with cobas¿ 4800 assays run on v1.1.1 of the cobas¿ 4800 system. Raw data review indicates that, in these cases, all signals are shifted by one channel: channel 1 results report as channel 2, channel 2 results report as channel 3, channel 3 results report as channel 4, and channel 4 results report as channel 1. In the reported
February 6, 2013Medical DevicesFDA
Roche Molecular Systems, Inc. recalls COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE.
Hazard: The COBAS TaqMan MTB Test Definition Files (TDF) v3.0, for both CE-IVD and JPN-IVD tests, being used with AMPLILINK software version 3.3 series and COBAS TaqMan MTB Test Kits, both CE-IVD and JPN-IVD, have an incorrect Target Elbow Max cutoff value of 48 creating the potential for false negative results to be generated for patient samples with Target Elbows in the range of 48 to 50.
January 2, 2013Medical DevicesFDA
Roche Molecular Systems, Inc. recalls COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrument used wit
Hazard: Certain COBAS AmpliPrep instruments using AMPILINK software v.3.3.4 had the sample clot detection flagging feature disabled during quality control release resulting in samples that may not be flagged as having clots.
December 19, 2012Medical DevicesFDA
Roche Molecular Systems, Inc. recalls DataCare POC is an information management system that provides data management functionality for managing point-of -ca
Hazard: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
December 19, 2012Medical DevicesFDA
Roche Molecular Systems, Inc. recalls DataCara GM is an information management system that provides data management functionality for managing blood glucose t
Hazard: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.