Cepheid: Medical Device Recall in 2025 - (Recall #: Z-0724-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 5, 2025

Date Posted: December 3, 2025

Recall Number: Z-0724-2026

Event ID: 97911

Reason for Recall:

Product testing did not meet expected stability criteria.

Status: Ongoing

Product Quantity: 9,880 units

Code Information:

Model Number: GXMTB/RIF-US-10. UDI-DI: 07332940000912. Batch: 1000812229. Lot: 41302. Expiration Date: 2025-02-02

Distribution Pattern:

US Nationwide distribution and Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated