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Cepheid recalls Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Recalled December 3, 2025 · FDA recall Z-0724-2026 · Cepheid
Hazard
Product testing did not meet expected stability criteria. · FDA Class II
Units
9,880 units
Sold at
US Nationwide distribution and Puerto Rico.
Description
Product testing did not meet expected stability criteria.
Product
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Manufacturer(s)
Cepheid
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →