FDA Medical devices recall ·
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10 recall
- Recall number
- Z-0724-2026
- Date
- (initiated November 5, 2025)
- Company / brand
- Cepheid
904 E Caribbean Dr, Sunnyvale, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 9,880 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Why was it recalled?
Product testing did not meet expected stability criteria.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: GXMTB/RIF-US-10. UDI-DI: 07332940000912. Batch: 1000812229. Lot: 41302. Expiration Date: 2025-02-02
Distribution
US Nationwide distribution and Puerto Rico.
States: Puerto Rico
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0724-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.