The Xpert MTB/RIF diagnostic test, model GXMTB/RIF-US-10 (UDI‑DI 07332940000912; batch 1000812229; lot 41302; expiration 2025-02-02), distributed nationwide in the United States and Puerto Rico, is being recalled by Cepheid. The recall was initiated because product testing did not meet expected stability criteria.
What's being recalled
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Recalling firm: Cepheid, Sunnyvale, CA, United States.
How to identify it
Model Number: GXMTB/RIF-US-10. UDI-DI: 07332940000912. Batch: 1000812229. Lot: 41302. Expiration Date: 2025-02-02
The hazard
Product testing did not meet expected stability criteria.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution and Puerto Rico.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)