Class IIReported 2025-12-03

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

Recalled by Cepheid

Reason for Recall

Product testing did not meet expected stability criteria.

Recall Number

Z-0724-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2025-11-05

Reported

2025-12-03

Distribution

US Nationwide distribution and Puerto Rico.

Code Info

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

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.