Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
FDA Recall #Z-0724-2026 — Class II — November 5, 2025
Product Description
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Reason for Recall
Product testing did not meet expected stability criteria.
Recalling Firm
Cepheid — Sunnyvale, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
9,880 units
Distribution
US Nationwide distribution and Puerto Rico.
Code Information
Model Number: GXMTB/RIF-US-10. UDI-DI: 07332940000912. Batch: 1000812229. Lot: 41302. Expiration Date: 2025-02-02
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated