cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System — Class II medical device recall Z-2498-2021
Terminated recall by Roche Molecular Systems, Inc., reported 2021-09-29, distributed nationwide. Customers have reported an increased number of false positive SARS-CoV-2 results.
| Recall number | Z-2498-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Molecular Systems, Inc., Branchburg, NJ, United States |
| Recall initiated | 2021-08-04 |
| Classified | 2021-09-21 |
| Reported by FDA | 2021-09-29 |
| Terminated | 2024-02-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CA, DE, DK, ES, FI, FR, GB, HR, NL, NO, PL, SK |
| Lot numbers | 10119Z |
| Model numbers | 09211101190 |
Product
cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
Reason for recall
Customers have reported an increased number of false positive SARS-CoV-2 results.
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-2498-2021. 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.