Z-0724-2026Class II

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

Name: Z-0724-2026 Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10
Creator: Cepheid
Published: 2025-11-05
License: https://open.fda.gov/license/

Cepheid / initiated 2025-11-05 / Open, Classified

FDA source

Cepheid began a recall of Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10 on 2025-11-05. FDA classified it as Class II and gives the reason as "Product testing did not meet expected stability criteria". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0724-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-05
Posted: 2025-11-26
Recalling firm: Cepheid
Product: Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Product code: PEU System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen
Reason for recall: Product testing did not meet expected stability criteria.
FDA 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 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 commerce: 9,880 units
Distribution: US Nationwide distribution and Puerto Rico.
Product codes and lots: Model Number: GXMTB/RIF-US-10. UDI-DI: 07332940000912. Batch: 1000812229. Lot: 41302. Expiration Date: 2025-02-02

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0724-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0724-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-03	2025-11-26

Product code PEU

K143302Class IIXpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80Cepheid / cleared 2015-02-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)