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U.S. Department of Health and Human Services

Class 2 Device Recall Xpert MTB/RIF

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 Class 2 Device Recall Xpert MTB/RIFsee related information
Date Initiated by FirmNovember 05, 2025
Date PostedNovember 26, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0724-2026
Recall Event ID 97911
510(K)NumberK143302 
Product Classification System, nucleic acid-based, mycobacterium tuberculosis complex, resistance marker, direct specimen - Product Code PEU
ProductXpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Code Information Model Number: GXMTB/RIF-US-10. UDI-DI: 07332940000912. Batch: 1000812229. Lot: 41302. Expiration Date: 2025-02-02
FEI Number 3004530258
Recalling Firm/
Manufacturer		 Cepheid
904 E Caribbean Dr
Sunnyvale CA 94089-1189
For Additional Information ContactDarwa Peterson
001-408-2427380
Manufacturer Reason
for Recall		Product testing did not meet expected stability criteria.
FDA Determined
Cause 2		Under Investigation by firm
ActionCephid 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.
Quantity in Commerce9,880 units
DistributionUS Nationwide distribution and Puerto Rico.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = PEU
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