cobas Influenza A/B & RSV UC — Class II medical device recall Z-1106-2023
Ongoing recall by Roche Molecular Systems, Inc., reported 2023-02-15, distributed nationwide. The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Targ
| Recall number | Z-1106-2023 |
|---|---|
| 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 | 2022-12-21 |
| Classified | 2023-02-07 |
| Reported by FDA | 2023-02-15 |
| Distributed | Nationwide (US) |
| Quantity | 727 kits |
| UPC / GTIN / UDI-DI | 00875197006773 |
Product
cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems; Material number 09233962190
Reason for recall
The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to additional testing, psychological distress, and delays to targeted therapy for influenza as well as true diagnosis.
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-1106-2023. 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.