FDAHealthNovember 5, 2025
Cepheid — Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
⚠️ Product testing did not meet expected stability criteria.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- November 5, 2025
US Nationwide distribution and Puerto Rico.
What's affected?
- Product
- Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
- Brand
- Cepheid
- Lot code
- 41302
Additional details
Model Number: GXMTB/RIF-US-10. UDI-DI: 07332940000912. Batch: 1000812229. Lot: 41302. Expiration Date: 2025-02-02
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 9,880 units.
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