Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10. Recalled by Cepheid Due to Product testing did not meet expected stability criteria.

Date: November 5, 2025
Company: Cepheid
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Cepheid directly.

Affected Products

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

Quantity: 9,880 units

Why Was This Recalled?

Product testing did not meet expected stability criteria.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Cepheid

Cepheid has 12 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report