Beckman Coulter — Class II medical device recall Z-2428-2024
Ongoing recall by Beckman Coulter Inc., reported 2024-07-31, distributed nationwide. LIH Influence check settings for Lipemia are incorrect which may result patient samples being reported as fals
| Recall number | Z-2428-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2024-05-27 |
| Classified | 2024-07-24 |
| Reported by FDA | 2024-07-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, FR, GB, GR, HK, HR, HU, IE, IL, IN, IQ, IT, JO, KR, LB, LK, LT, MA, MX, MY, NL, NZ, OM, PE, PH, PK, PL, PT, QA, RO, RS, SA, SG, SK, TN, TR, TW, UA, VN, ZA |
| Quantity | 13,565 units |
| UPC / GTIN / UDI-DI | 15099590011598 |
| Lot numbers | 2548, 2549, 2550, 2551, 2552, 2553, 2554 |
| Model numbers | 4X11, 4X14, OSR61173 |
| Expiration dates | 2024-06-01, 2024-10-01, 2024-11-01, 2025-04-01, 2025-07-01, 2025-10-01, 2026-03-01 |
Product
Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2
Reason for recall
LIH Influence check settings for Lipemia are incorrect which may result patient samples being reported as false low results or cause a high result to report as normal
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-2428-2024. 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.