Recall Z-1413-2021— Roche Molecular Systems, Inc.
Class II · Ongoing
Class II FDA medical device recall by Roche Molecular Systems, Inc., initiated 2021-03-25. FDA's recall record names no specific 510(k) clearance for this event. 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. 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, showed abnormal PCR growth curves.
- Recalling firm
- Roche Molecular Systems, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-03-25
- Firm location
- Branchburg, NJ, United States
Product description
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
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.