Roche Molecular Systems recalls
4 official recalls and safety alerts involving Roche Molecular Systems since 2021-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Roche Molecular Systems or the relevant agency.
- 2023-02-15
USRoche 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 Number…
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,…
FDA · DeviceRoche Molecular Systems, Inc.Domestic distribution nationwide. Foreign distribution worldwide.Official notice →- 2022-10-26
- US
Roche Molecular Systems, Inc. recalls cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing…
Reported false positive and invalid results on the affected devices due to anomalous baselines. This may lead to erroneous or delayed diagnoses.
FDA · DeviceRoche Molecular Systems, Inc.International distribution in the countries of Austria, Belgium, Czech…Official notice → - 2022-04-06
- US
Roche Molecular Systems, Inc. recalls cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
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…
FDA · DeviceRoche Molecular Systems, Inc.Worldwide distribution - US Nationwide distribution in the states of CO, IL,…Official notice → - 2021-10-20
- US
Roche Molecular Systems, Inc. recalls cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment
FDA · DeviceRoche Molecular Systems, Inc.Worldwide distribution - US Nationwide distribution and the countries of…Official notice →