Class II
Medical Device Recall: Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Cepheid · November 5, 2025
Reason for Recall
Product testing did not meet expected stability criteria.
Distribution
US Nationwide distribution and Puerto Rico.
States Affected
NATIONWIDE
Quantity Affected
9,880 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0724-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.