FDA-Device2025-12-03Class IIPROCESSING DEFECT
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Hazard
Product testing did not meet expected stability criteria.
Intended for
All ages
Illnesses reported
None reported
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-0724-2026Want us to check the next one for you?
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