FDA Device recall Z-0724-2026
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10
- FDA Device
- Class II
- ongoing
- Published 2025-12-03
On 2025-12-03 the FDA classified a Class II recall of Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10 by Cepheid, citing product testing did not meet expected stability criteria.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0724-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-11-05 |
| Published | 2025-12-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Cepheid |
| Distribution | US |
Product
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Reason
Product testing did not meet expected stability criteria.
Identifiers
| code_info | Model Number: GXMTB/RIF-US-10. UDI-DI: 07332940000912. Batch: 1000812229. Lot: 41302. Expiration Date: 2025-02-02 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Cepheid
- Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10
FDA Device · Class II · 2025-12-24 · Cepheid - Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
FDA Device · Class II · 2025-12-24 · Cepheid - Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit
FDA Device · Class II · 2025-11-05 · Cepheid - Cepheid, Sample Collection Device, Part: 900-0370
FDA Device · Class II · 2024-08-21 · Cepheid - Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only
FDA Device · Class II · 2023-11-08 · Cepheid
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0724-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.