FDA recall Z-0724-2026
Cepheid · Class II · device
Product
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Reason for recall
Product testing did not meet expected stability criteria.
Distribution
US Nationwide distribution and Puerto Rico.
Key facts
- Status
- Ongoing
- Initiation date
- 2025-11-05
- Report date
- 2025-12-03
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Sunnyvale, CA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0724-2026