Medical device recalls Moderate risk

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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