Xpert MTB/RIF recall
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Why was Xpert MTB/RIF recalled?
Product testing did not meet expected stability criteria.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: GXMTB/RIF-US-10. UDI-DI: 07332940000912. Batch: 1000812229. Lot: 41302. Expiration Date: 2025-02-02
- Product
- Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
- Recalling firm
- Cepheid
- Quantity
- 9,880 units
- Distribution
- US Nationwide distribution and Puerto Rico.
- Recall date
- December 3, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)