Cepheid recalls Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
- Recall date
- November 5, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0724-2026
- FDA classification
- Class II
- Brand / firm
- Cepheid
- Sold / distributed
- US Nationwide distribution and Puerto Rico.
Why it was recalled
Product testing did not meet expected stability criteria.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
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