Recall Z-1413-2021 ยท QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
Roche Molecular Systems, Inc.
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
| Date | Mar 25, 2021 |
| Status | Open, Classified |
| 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 |
| Root cause | Unknown/Undetermined by firm |
| Action | Roche issued Urgent Medical Device Correction letter on March 25, 2021. Letter states reason for recall, health risk and action to take: Actions Required " Inform any operators that use the cobas Liat analyzer and/or cobas SARS-CoV-2 & Influenza A/B test of the potential hazards associated with this issue and provide a copy of this UMDC as appropriate. " If you observe an increase in Influenza B positive results that does not match community infection rates, stop testing on the cobas Liat analyzer and contact the Roche Support Network Customer Support Center at 1-800-800-5973 to determine if a |
| Quantity | US: 143,823 kits Ex-US: 57,219 kits |
| Distribution | Nationwide WorldWide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.