Device product
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Z-0724-2026
Product summary
- Firm
- Cepheid
- Event
- Event 97911
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 9,880 units
- Official record key
device-enforcement:Z-0724-2026
Official wording
Reason: Product testing did not meet expected stability criteria.
Code information: Model Number: GXMTB/RIF-US-10. UDI-DI: 07332940000912. Batch: 1000812229. Lot: 41302. Expiration Date: 2025-02-02
Distribution pattern: US Nationwide distribution and Puerto Rico.
Derived failure modes
-
Unknown
Product testing did not meet expected stability criteria.