Xpert MTB/RIF — Class II medical device recall Z-0724-2026
Ongoing recall by Cepheid, reported 2025-12-03, distributed nationwide. Product testing did not meet expected stability criteria.
| Recall number | Z-0724-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cepheid, Sunnyvale, CA, United States |
| Recall initiated | 2025-11-05 |
| Classified | 2025-11-26 |
| Reported by FDA | 2025-12-03 |
| Distributed | Nationwide (US) |
| Quantity | 9,880 units |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 07332940000912 |
| Lot numbers | 1000812229, 41302 |
| Model numbers | GXMTB/RIF-US-10 |
| Expiration dates | 2025-02-02 |
Product
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Reason for recall
Product testing did not meet expected stability criteria.
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-0724-2026. 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.