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Roche Molecular Systems, Inc. FDA Recalls
9 recalls on file across devices, 0 of them Class I and 7 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190Class IIDec 21, 2022The firm received customer complaints regarding false negati |
| cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems; MatClass IIDec 21, 2022The firm received customer complaints regarding false negati |
| cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material NumClass IIDec 21, 2022The firm received customer complaints regarding false negati |
| cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid TClass IISep 8, 2022Reported false positive and invalid results on the affected |
| cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190Class IINov 16, 2021Roche has identified a small number of cobas Liat analyzer u |
| cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190Class IISep 3, 2021False Mutation Detected results for the exon 20 insertion (E |
| cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190Class IIAug 4, 2021Customers have reported an increased number of false positiv |
| cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190Class IIMar 25, 2021Invalid or false positive results for one or more targets (S |
| cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas LiClass IIMar 25, 2021Invalid or false positive results for one or more targets (S |