Cepheid recalls Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.

Product testing did not meet expected stability criteria.

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.

• FDA enforcement recordOfficial FDA database entry for Z-0724-2026
• FDA 510(k) clearance · K143302The device's official FDA premarket clearance record
• FDA device classification · PEUOfficial FDA classification for this device type
• CFR regulation · 21 CFR 866.3373The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find CepheidSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.