Recall Z-0724-2026 ยท PEU System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen
Cepheid
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
| Date | Nov 26, 2025 (initiated Nov 5, 2025) |
| Status | Open, Classified |
| Reason | Product testing did not meet expected stability criteria. |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 9,880 units |
| Distribution | US Nationwide distribution and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143302 | Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80 Cepheid, Feb 12, 2015 |