cobas LiatSystem — Class II medical device recall Z-0828-2022
Ongoing recall by Roche Molecular Systems, Inc., reported 2022-04-06, distributed nationwide. Roche has identified a small number of cobas Liat analyzer units that have consistently high noise levels (bac
| Recall number | Z-0828-2022 |
|---|---|
| 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 | 2021-11-16 |
| Classified | 2022-03-28 |
| Reported by FDA | 2022-04-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | CY, ES, HK |
| Quantity | 14 units |
| UPC / GTIN / UDI-DI | 07613336100097 |
| Serial numbers | 16333, 16454, 16688, 16695, 16871, 16914, 17048, 17086, 17116, 17266, 18094, 18323, 18357, 19924 |
Product
cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
Reason for recall
Roche has identified a small number of cobas Liat analyzer units that have consistently high noise levels (background signal) originating from the amber detector (used for Influenza B detection). This noise increases the probability of false positive Influenza B 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-0828-2022. 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.