Xpert Xpress Strep A — Class II medical device recall Z-0215-2024
Ongoing recall by Cepheid, reported 2023-11-08, distributed nationwide. pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invali
| Recall number | Z-0215-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cepheid, Sunnyvale, CA, United States |
| Recall initiated | 2023-04-24 |
| Classified | 2023-11-02 |
| Reported by FDA | 2023-11-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CH, CR, DE, EE, GB, GR, HK, IE, IT, PL |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 07332940006372 |
| Lot numbers | 10309, 23113, 23201, 23305, 23308, 23312, 23314, 23315, 23316, 23401, 23402, 23403, 23404, 23405, 23406, 23407, 23408, 23410, 23411, 23501, 23504, 23505, 23506, 23510, 23604, 23605, 23607, 23608, 23609, 23610, 23611, 23612, 23701, 23702, 23703, 23705, 23706, 23707, 23708, 23709 and 30 more |
Product
Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only
Reason for recall
pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results or no result 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-0215-2024. 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.