Home / Recalls / Cepheid / Z-0724-2026

Z-0724-2026 Class II Ongoing

Recalled by Cepheid — Sunnyvale, CA

Recall Details

Product Type
Devices
Report Date
December 3, 2025
Initiation Date
November 5, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9,880 units

Product Description

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

Reason for Recall

Product testing did not meet expected stability criteria.

Distribution Pattern

US Nationwide distribution and Puerto Rico.

Code Information

Model Number: GXMTB/RIF-US-10. UDI-DI: 07332940000912. Batch: 1000812229. Lot: 41302. Expiration Date: 2025-02-02

Other recalls by Cepheid

  • Z-0959-2026 Class II — Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10 (October 30, 2025)
  • Z-0960-2026 Class II — Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10 (October 30, 2025)
  • Z-0414-2026 Class II — Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 0733294000015 (August 6, 2025)
  • Z-2584-2024 Class II — Cepheid, Sample Collection Device, Part: 900-0370 (June 20, 2024)
  • Z-0216-2024 Class II — Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD, (April 24, 2023)
  • Z-0215-2024 Class II — Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only (April 24, 2023)
  • Z-0592-2018 Class II — Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 10000 (October 9, 2017)
  • Z-0028-2018 Class II — Xpert EV Assay, Catalog GXEV-100N-10. The Cepheid Xpert EV assay is a reverse (September 15, 2017)
  • Z-2548-2016 Class II — Xpert MRSA Catalog GXMRSA-120, Rev. AJ Microbiology: The Cepheid Xpert MR (July 18, 2016)
  • Z-2432-2015 Class III — Xpert CT/NG Urine Specimen Collection Kit Part number GXCT/NGURINE-50; Micro (July 27, 2015)