Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
FDA device recall Z-0724-2026 · posted 2025-11-26 · Open, Classified
Recall details
- Recalling firm
- Cepheid
- Reason for recall
- Product testing did not meet expected stability criteria.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- PEU
- Quantity affected
- 9,880 units
- Distribution
- US Nationwide distribution and Puerto Rico.
- Date initiated
- 2025-11-05
- Date posted
- 2025-11-26
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80 (K143302) | Cepheid | 2015-02-12 |