Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10 recallZ-0724-2026 · Cepheid · initiated Nov 5, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cepheid or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product testing did not meet expected stability criteria.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-0724-2026
- Status
- Open, Classified
- Initiated by the company
- Nov 5, 2025
- Posted by the FDA
- Nov 26, 2025
- Recalling firm
- Cepheid
- Quantity
- 9,880 units
- Product code
- PEU
- FDA submissions
- K143302
- Distribution
- US Nationwide distribution and Puerto Rico.
Product description
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Code information (models, lots, serial numbers)
Model Number: GXMTB/RIF-US-10. UDI-DI: 07332940000912. Batch: 1000812229. Lot: 41302. Expiration Date: 2025-02-02
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Xpert MTB/RIF GXMTB/RIF-US-10Cepheid · System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen1 recall3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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