Apo B Reagent — Class III medical device recall Z-1815-2025
Ongoing recall by Beckman Coulter Ireland, Inc., reported 2025-06-04, distributed nationwide. The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included
| Recall number | Z-1815-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Ireland, Inc., O'Callaghan'S Mills, N/A, Ireland |
| Recall initiated | 2025-04-23 |
| Classified | 2025-05-23 |
| Reported by FDA | 2025-06-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BE, BG, CA, CH, CN, CZ, DE, EE, EG, ES, FR, GB, GH, GR, HK, IE, IL, IN, IT, KR, MY, NL, NZ, SA, SK, TW, VN |
| Quantity | 2,747 units |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 15099590010409 |
| Lot numbers | 2631 |
| Model numbers | OSR6143 |
Product
Apo B Reagent, REF: OSR6143
Reason for recall
The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B patient result which could exceed the total allowable error for the APO B assay (11.6%). The error results in results with a positive bias up to 42%. However, based on the mitigating factors the risk to health is considered to be negligible or limited.
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-1815-2025. 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.