Reported Dec 3, 2025 · Ongoing
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Cepheid
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cepheid · 904 E Caribbean Dr · Sunnyvale, CA · 94089-1189
Is this the product you have?
- Xpert MTB/RIF
- Model NumberGXMTB/RIF-US-10
- Lot codes and dates
- Model NumberGXMTB/RIF-US-10
- UDI-DI07332940000912
- Batch1000812229
- Lot41302
- Expiration Date2025-02-02
- Amount recalled
- 9,880 units
Where it was sold
- Nationwide
- PR
Why it was recalled
Product testing did not meet expected stability criteria.
This product could cause temporary or reversible health problems — stop using it.
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