Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10. (Cepheid) – product testing did not meet expected... (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Brand
Cepheid
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Model Number: GXMTB/RIF-US-10. UDI-DI: 07332940000912. Batch: 1000812229. Lot: 41302. Expiration Date: 2025-02-02
Cepheid is recalling Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10. due to Product testing did not meet expected stability criteria.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product testing did not meet expected stability criteria.
Recommended Action
Per FDA guidance
Cephid notified consignees on about 11/05/2025 via FedEx letter. Consignees were instructed to ensure no affected units remain in inventory or are available for use since the affected lots have passed their expiration date. Past results obtained from Xpert MTB/RIF batch 1000812229 lot 41302 may be inaccurate. If these results were used to make clinical management decisions, it is recommended that the results be reviewed in the context of corresponding culture data, drug susceptibility testing, clinical presentation and other relevant laboratory information to ensure accurate patient care. If there is uncertainty or insufficient information to confirm the result, repeat testing to ensure accuracy. Consignees were requested to notify relevant clinical teams as needed. Cepheid will provide products for the purposes of retesting. Kits are expected to ship within 5 business days following receipt of the completed response form. Additionally, consignees were instructed to complete and return the Customer Response Form.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026