Recall Z-0724-2026— Cepheid

Name: FDA recall Z-0724-2026
Creator: U.S. Food and Drug Administration
Published: 2025-11-05

Class II · Ongoing

Class II FDA medical device recall by Cepheid, initiated 2025-11-05. It names one FDA 510(k) clearance: K143302. Product: Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.. Reason: Product testing did not meet expected stability criteria..

Recalling firm: Cepheid
Classification: Class II
Status: Ongoing
Initiated: 2025-11-05
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K143302 — Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80Cepheid·cleared 2015-02-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Product testing did not meet expected stability criteria.

Data sourced from openFDA. This site is unofficial and independent of the FDA.