FDA-Device2025-12-03Class II
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Cepheid
Hazard
Product testing did not meet expected stability criteria.
Sold states
US Nationwide distribution and Puerto Rico.
Affected count
9,880 units
Manufactured in
904 E Caribbean Dr, N/A, Sunnyvale, CA, United States
Products
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0724-2026Don't want to check this manually?
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