Roche Molecular Systems recalls
Roche Molecular Systems appears in 42 official U.S. recall notices indexed by RecallRadar, most recently on 2023-02-15.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 42 |
|---|---|
| Published | 2012-08-15 to 2023-02-15 |
| By agency | FDA Device (42) |
| By classification | Class II (37), Class III (5) |
| By status | terminated (35), ongoing (7) |
| Distribution named in notices | AK, CA, GA, HI, IA, LA, MA, MD, ME, MI, MN, MT, NC, NY, OR, PA, TX, US, VA, WA |
Recalls
- cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems
FDA Device · Class II · 2023-02-15 · Roche Molecular Systems
Reason: 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… - cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems
FDA Device · Class II · 2023-02-15 · Roche Molecular Systems
Reason: 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… - cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems
FDA Device · Class II · 2023-02-15 · Roche Molecular Systems
Reason: 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… - cobas 5800 instrument, Material No. 08707464001
FDA Device · Class II · 2022-10-26 · Roche Molecular Systems
Reason: Reported false positive and invalid results on the affected devices due to anomalous baselines. This may lead to erroneous or delayed diagnoses. - cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
FDA Device · Class II · 2022-04-06 · Roche Molecular Systems
Reason: 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 th… - cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
FDA Device · Class II · 2021-10-20 · Roche Molecular Systems
Reason: False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment - cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
FDA Device · Class II · 2021-09-29 · Roche Molecular Systems
Reason: Customers have reported an increased number of false positive SARS-CoV-2 results. - cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190
FDA Device · Class II · 2021-04-21 · Roche Molecular Systems
Reason: 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, showe… - cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Liat System, Catalog…
FDA Device · Class II · 2021-04-21 · Roche Molecular Systems
Reason: 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, showe… - uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
FDA Device · Class II · 2021-01-27 · Roche Molecular Systems
Reason: 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… - The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and detection system for nucleic…
FDA Device · Class II · 2021-01-20 · Roche Molecular Systems
Reason: Dirty Lens May Cause Invalid or False Positive Results - MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541089001 - Product Usage: This protocol is intended for pipettin…
FDA Device · Class II · 2020-07-22 · Roche Molecular Systems
Reason: 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. - MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24 System is a fully automated clinical sample extractor
FDA Device · Class II · 2018-06-06 · Roche Molecular Systems
Reason: Cross-contamination of samples has been reported when running the existing protocol on the system with the rack-based purification run. - Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic
FDA Device · Class II · 2018-04-04 · Roche Molecular Systems
Reason: 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… - 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 t…
FDA Device · Class II · 2016-12-21 · Roche Molecular Systems
Reason: 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 t… - cobas¿ Liat¿ Analyzer
FDA Device · Class II · 2016-07-27 · Roche Molecular Systems
Reason: 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 re… - cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2: 07248563190 cfDNA: 07247737190 Device Identifier: EGFR v2.0: 00875197005448 c…
FDA Device · Class II · 2016-07-27 · Roche Molecular Systems
Reason: 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… - cobas¿ Liat Influenza A/B Quality Control Kit
FDA Device · Class III · 2016-07-20 · Roche Molecular Systems
Reason: Kit labeled with the incorrect expiration date. - cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian Translation Instructions for Use
FDA Device · Class II · 2016-06-01 · Roche Molecular Systems
Reason: 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… - Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems
FDA Device · Class II · 2016-05-04 · Roche Molecular Systems
Reason: The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identified a sample barcode ID. - cobas Liat Analyzer, for in vitro diagnostic use
FDA Device · Class II · 2015-09-09 · Roche Molecular Systems
Reason: 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. - cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
FDA Device · Class III · 2015-04-01 · Roche Molecular Systems
Reason: False positive results for Exon 20 insertion mutations are being detected with the cobas¿ EGFR Mutation Test, kit batch T08661. - cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test
FDA Device · Class III · 2015-01-28 · Roche Molecular Systems
Reason: cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS Calibrator. - cobas¿ PCR Urine Kit 100 PKT IVD cobas¿ PCR Female Swab Kit 100 PKT IVD cobas¿ PCR media 100T IVD cobas¿ PCR Female Swab Kit 100 PKT JPN-IV…
FDA Device · Class II · 2014-03-05 · Roche Molecular Systems
Reason: 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. - KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System, Inc. 1080 US highway 202 South Branchburg, NJ 08876 USA Roche…
FDA Device · Class II · 2013-09-18 · Roche Molecular Systems
Reason: 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… - cobas¿ 4800 system z480 instrument
FDA Device · Class II · 2013-05-29 · Roche Molecular Systems
Reason: 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: cha… - COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE
FDA Device · Class II · 2013-02-06 · Roche Molecular Systems
Reason: 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… - COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrument used with CAP/CA and CAP/CTM.…
FDA Device · Class II · 2013-01-02 · Roche Molecular Systems
Reason: 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. - DataCare POC is an information management system that provides data management functionality for managing point-of -care testing data
FDA Device · Class II · 2012-12-19 · Roche Molecular Systems
Reason: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. - DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data
FDA Device · Class II · 2012-12-19 · Roche Molecular Systems
Reason: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. - The COBAS 8000 data manager modular analyzer series (all versions) is a is a fully automated, random-access, software- controlled system fo…
FDA Device · Class II · 2012-12-19 · Roche Molecular Systems
Reason: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. - Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS¿ AmpliPrep instrument, COBAS¿ Taq…
FDA Device · Class II · 2012-12-19 · Roche Molecular Systems
Reason: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. - The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer
FDA Device · Class II · 2012-12-19 · Roche Molecular Systems
Reason: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. - The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler instrument for automated isolation…
FDA Device · Class II · 2012-12-19 · Roche Molecular Systems
Reason: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. - 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)…
FDA Device · Class II · 2012-12-19 · Roche Molecular Systems
Reason: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. - The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation of nucleic acids in various type…
FDA Device · Class II · 2012-12-19 · Roche Molecular Systems
Reason: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. - LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nu…
FDA Device · Class II · 2012-12-19 · Roche Molecular Systems
Reason: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. - DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems…
FDA Device · Class II · 2012-12-19 · Roche Molecular Systems
Reason: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. - cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, Inc., Product Usage: The primary use of the cobas 4…
FDA Device · Class III · 2012-11-07 · Roche Molecular Systems
Reason: It was identified that BRAF controls dispositioned as "Internal Use Only" were incorrectly packaged into cobas 4800 BRAF V600 Mutation Test CE-IVD kit lot R03607 and released for distribution. Two control batches manufa… - Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan
FDA Device · Class II · 2012-09-26 · Roche Molecular Systems
Reason: When using a Laboratory Information system (LIS) with automated systems utilizing AMPLILINK software v3.2 series (AL v3.2) there is a potential for wrong results to be assigned to an order. - COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001
FDA Device · Class II · 2012-08-22 · Roche Molecular Systems
Reason: Certain lots of COBAS AmpliPrep (CAP) S-tube Input (Box of 12 bags 12x24 S-tube and 12x24 S-clip) can cause the sample input tubes to stick in the barcode clips. As a consequence, the CAP instrument will lift both the s… - Cobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage: The Cobas KRAS Mutation Test, for use with the Cobas 4800 System…
FDA Device · Class III · 2012-08-15 · Roche Molecular Systems
Reason: During the real-time stability testing for the cobas KRAS Mutation Test on the commercial lot PO6778, it was identified that the kit was just within specifications for the codon 61 peak height ratio, and that the kit ha…