⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Cepheid: Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.

Medical DevicesSource: FDA (device) · Date: 2025-12-03

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Cepheid
Product
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Reason / hazard
Product testing did not meet expected stability criteria.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution and Puerto Rico.
Recall initiated
2025-11-05
Code info
Model Number: GXMTB/RIF-US-10. UDI-DI: 07332940000912. Batch: 1000812229. Lot: 41302. Expiration Date: 2025-02-02
Product quantity
9,880 units
Voluntary mandated
Voluntary: Firm initiated
City
Sunnyvale
State
CA
Country
United States
Event id
97911
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