The Recall Desk

Manufacturer

Roche Molecular Systems, Inc.

42 recalls in our database name Roche Molecular Systems, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
42
Critical
0
Severe
1
Most recent
2023-02-15

Of the 42 recalls from Roche Molecular Systems, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (2%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 42

  • HighFDA (Devices)·Z-1104-2023·2023-02-15

    Roche cobas Flu/COVID assay recalled for false negative influenza results

    Roche Molecular Systems recalls cobas SARS-CoV-2 & Influenza A/B assay kits used in clinical laboratories. The kits may produce false negative Influenza A results, potentially delaying accurate diagnosis.

    Product
    cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1106-2023·2023-02-15

    Roche Influenza A/B and RSV Test Kit Recalled for False Negative Results

    Roche Molecular Systems recalled 727 diagnostic test kits used to detect influenza and RSV due to reports of false negative influenza A results that could delay proper diagnosis and treatment.

    Product
    cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems; Material number 09233962190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1105-2023·2023-02-15

    Roche cobas Influenza Test Recall Due to False Negative Results

    Roche Molecular Systems is recalling its cobas Influenza A/B & SARS-CoV-2 test because it has reported false negative results for Influenza A, which may delay diagnosis and treatment.

    Product
    cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number 09446125190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0097-2023·2022-10-26

    Medical Device Recall: Roche cobas 5800 False Results Due to Baseline Anomalies

    Roche Molecular Systems recalls the cobas 5800 PCR testing instrument due to false positive and invalid results caused by anomalous baselines. This may lead to erroneous or delayed diagnoses.

    Product
    cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0828-2022·2022-04-06

    Cobas Liat respiratory virus analyzer units recalled for false Influenza B results

    Roche is recalling 14 Cobas Liat analyzer units due to detector noise causing false positive Influenza B results. Affected units were distributed in seven U.S. states and three countries.

    Product
    cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0083-2022·2021-10-20

    Cobas EGFR Mutation Test v2 may return false mutation detection results

    The cobas EGFR Mutation Test v2 may produce false positive results for exon 20 insertion mutations, potentially leading to inappropriate treatment. Healthcare providers should verify detected mutations using alternative methods.

    Product
    cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2498-2021·2021-09-29

    cobas SARS-CoV-2 and Influenza A/B Test Recalled Due to False Positive Results

    Roche Molecular Systems is recalling cobas SARS-CoV-2 & Influenza A/B test kits following reports of increased false positive SARS-CoV-2 results.

    Product
    cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1414-2021·2021-04-21

    Roche cobas Liat Analyzer Respiratory Virus Panel Recall

    Roche is recalling the cobas Liat Analyzer respiratory virus panel due to invalid or false positive results for SARS-CoV-2 and Influenza A/B.

    Product
    cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1413-2021·2021-04-21

    Roche Recalls cobas SARS-CoV-2 and Influenza Assay Reagents

    Roche is recalling cobas SARS-CoV-2 & Influenza A/B assay reagents because they may produce invalid or false positive results.

    Product
    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: 09211101190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0877-2021·2021-01-27

    Roche uPath software 1.1 recalled for incorrect measurement calculations

    Roche Molecular Systems is recalling uPath software 1.1 because measurement values are incorrectly calculated in Split View mode when slides have different magnifications.

    Product
    uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0846-2021·2021-01-20

    Roche cobas z 480 Analyzer Recalled for Dirty Lens Risk

    Roche is recalling cobas z 480 analyzers because a dirty lens may cause invalid or false positive results.

    Product
    The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and detection system for nucleic acids. The analyzer is intended to be used as an in-vitro diagnostic or screening system providing real time PCR amplification and detection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2551-2020·2020-07-22

    Roche MagNA Pure 96 Instrument Recalled for Cross-Contamination Risk

    Roche is recalling 917 MagNA Pure 96 instruments because a specific protocol version fails to activate the drop catcher, posing a risk of cross-contamination and erroneous results.

    Product
    MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541089001 - Product Usage: This protocol is intended for pipetting samples into a MagNA Pure 96 Processing Cartridge (purification rack position 1) before a purification run.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1956-2018·2018-06-06

    Roche MagNA Pure 24 System Recalled for Sample Cross-Contamination

    Roche Molecular Systems is recalling 163 MagNA Pure 24 automated clinical sample extractors due to reported cross-contamination of samples during rack-based purification runs.

    Product
    MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24 System is a fully automated clinical sample extractor. It extracts nucleic acids from various sample types, sample tubes, and volume inputs for multiple downstream applications. The main features of the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1195-2018·2018-04-04

    Roche Recalls cobas MRSA/SA Nucleic Acid Tests for Decreased Performance

    Roche Molecular Systems is recalling cobas MRSA/SA tests worldwide due to decreased performance that may lead to screening failures and potential infection spread.

    Product
    Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0750-2017·2016-12-21

    Roche Recalls LightMix Zika rRT-PCR Test Due to False Positive Risk

    Roche Molecular Systems is recalling the LightMix Zika rRT-PCR Test because the software algorithm may occasionally report false positive results.

    Product
    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 virus in serum or EDTA plasma from individuals meeting CDC Zika virus clinical criteria (e.g., clinical signs and symptoms associate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2254-2016·2016-07-27

    Roche Recalls cobas EGFR Mutation Test V2 Due to False Negatives

    Roche Molecular Systems is recalling cobas EGFR Mutation Test V2 kits because internal studies found they may produce false negative results when used with the cfDNA Sample Preparation kit.

    Product
    cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2: 07248563190 cfDNA: 07247737190 Device Identifier: EGFR v2.0: 00875197005448 cfDNA: 00875197005424 Product Usage: A real time PCR Test for the qualitative detection and identifications of mutations n exons
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2203-2016·2016-07-20

    Roche Recalls Influenza Quality Control Kits Due to Incorrect Expiration Dates

    Roche Molecular Systems is recalling 194 cobas Liat Influenza A/B Quality Control Kits because they are labeled with incorrect expiration dates.

    Product
    cobas¿ Liat Influenza A/B Quality Control Kit; For use with cobas¿ Liat Influenza A/B Assay.
    Category
    Medical Device
    Distribution
    16 states
  • LowFDA (Devices)·Z-1830-2016·2016-06-01

    Roche Recalls Hungarian Instructions for cobas EGFR Mutation Test Kits

    Roche is recalling 8 kits of cobas EGFR Mutation Test v2 and cfDNA Sample Preparation due to errors in the Hungarian translated instructions for use.

    Product
    cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian Translation Instructions for Use
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1578-2016·2016-05-04

    Roche IT3800 Hand-Held Barcode Scanner Recalled for Mis-Identification

    Roche Molecular Systems is recalling 6,939 IT3800 hand-held barcode scanners because they mis-identified sample barcodes when used with the COBAS AmpliPrep instrument.

    Product
    Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2543-2015·2015-09-09

    Roche Recalls cobas Liat Analyzers Due to Incorrect LED Components

    Roche Molecular Systems is recalling five cobas Liat Analyzers because incorrect LED components were used in the printed circuit board assemblies.

    Product
    cobas Liat Analyzer, for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1320-2015·2015-04-01

    Roche Recalls cobas EGFR Mutation Test Kits Due to False Positives

    Roche Molecular Systems is recalling 190 kits of the cobas EGFR Mutation Test because they may produce false positive results for Exon 20 insertion mutations.

    Product
    cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0999-2015·2015-01-28

    Roche Recalls cobas 4800 KRAS Mutation Test Kits for Invalid Results

    Roche Molecular Systems is recalling cobas 4800 KRAS Mutation Test kits because they are generating invalid results for the Mutant Control and/or KRAS Calibrator.

    Product
    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 KRAS Gene in DNA derived from formalin-fixed paraffin-embedded human colorectal and non-small cell lung cancer tissues.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1111-2014·2014-03-05

    Roche Recalls Leaking cobas PCR Urine and Swab Test Kits

    Roche Molecular Systems is recalling 84 batches of cobas PCR Urine, Female Swab, and media kits due to reports of leaking media.

    Product
    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-IVD Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 The cobas
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2173-2013·2013-09-18

    Roche Recalls cobas 4800 HPV Test Kits Due to Formulation Error

    Roche Molecular Systems is recalling specific lots of cobas 4800 HPV test kits because a formulation error was identified during the manufacture of the Master Mix reagent.

    Product
    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 Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 USA The cobas¿ HPV Test is a qualitative in vitro test for the detection of Hum
    Category
    Medical Device
    Distribution
    Distributed nationwide