cobas Liat Analyzer: respiratory virus panel nucleic acid assay… — Class II medical device recall Z-1414-2021
Ongoing recall by Roche Molecular Systems, Inc., reported 2021-04-21, distributed nationwide. Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) using the cobas
| Recall number | Z-1414-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Molecular Systems, Inc., Branchburg, NJ, United States |
| Recall initiated | 2021-03-25 |
| Classified | 2021-04-12 |
| Reported by FDA | 2021-04-21 |
| Distributed | Nationwide (US) |
| Reason classes | potency |
| Model numbers | 07341920190 |
Product
cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1414-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.