Class II — Cepheid
| Recalling firm | CEPHEID |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Product testing did not meet expected stability criteria. |
| Product | Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10. |
| Quantity | 9,880 units |
| Distribution | US Nationwide distribution and Puerto Rico. |
| Initiated | 2025-11-05 |
| Classified | 2025-11-26 |
| Recall number | Z-0724-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Cepheid (Z-0724-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97911/
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