Recall archive / FDA device enforcement
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10. — FDA record Z-0724-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 5, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
- Reason
- Product testing did not meet expected stability criteria.
- Classification
- Class II
- Recalling firm
- Cepheid
- Quantity
- 9,880 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0724-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model Number: GXMTB/RIF-US-10. UDI-DI: 07332940000912. Batch: 1000812229. Lot: 41302. Expiration Date: 2025-02-02 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution and Puerto Rico.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Dec 3, 2025
- Recall initiation date
- Nov 5, 2025
- Center classification date
- Nov 26, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.