Cepheid — Class II medical device recall Z-2584-2024
Ongoing recall by Cepheid, reported 2024-08-21, distributed nationwide. Specimen collection device may leak after the patient sample swabs have been inserted into the test tubes, whi
| Recall number | Z-2584-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cepheid, Sunnyvale, CA, United States |
| Recall initiated | 2024-06-20 |
| Classified | 2024-08-13 |
| Reported by FDA | 2024-08-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BE, CH, CL, CO, DE, DK, EC, ES, FI, FR, GB, HK, IE, IT, KW, MX, NI, NL, OM, PL, PT |
| Quantity | 651,150 |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 28053326001523 |
| Lot numbers | 230397900, 230535300, 230627500, 231877400 |
| Model numbers | 900-0370 |
Product
Cepheid, Sample Collection Device, Part: 900-0370
Reason for recall
Specimen collection device may leak after the patient sample swabs have been inserted into the test tubes, which could result in biohazard exposure, cross contamination causing false positive results for other specimens, and/or delay to test results.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2584-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.