UIBC — Class II medical device recall Z-2264-2025
Ongoing recall by Beckman Coulter Inc., reported 2025-08-13, distributed in AK, AL, AR, CO, CT, DC, DE, GA…. Beckman Coulter identified that the Unsaturated Iron Binding Capacity (UIBC) assay is not meeting their labele
| Recall number | Z-2264-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2025-06-26 |
| Classified | 2025-08-04 |
| Reported by FDA | 2025-08-13 |
| Distributed | AK, AL, AR, CO, CT, DC, DE, GA, ID, PR, UT |
| Countries outside the US | AE, AR, AU, BD, BE, BG, BH, BR, CA, CN, CO, CR, CZ, DE, DZ, EG, ES, GB, GH, GR, HK, HR, HU, ID, IE, IL, IN, IT, JO, KR, KW, LB, LK, LT, MA, MX, MY, NG, NL, NP, OM, PA, PE, PH, PK, PL, PT, QA, RO, RS, SA, SE, SG, SK, SV, TH, TN, TR, TW, VN, ZA |
| Quantity | 56,696 units |
| Reason classes | labeling, potency |
| UPC / GTIN / UDI-DI | 15099590011925 |
| Model numbers | OSR61205 |
Product
UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,
Reason for recall
Beckman Coulter identified that the Unsaturated Iron Binding Capacity (UIBC) assay is not meeting their labeled hemoglobin interference claims of no significant interference (i.e., less than 10%) up to 200 mg/dL hemoglobin as indicated in their instructions for use. Initial internal testing confirmed that samples with low UIBC levels failed the claimed hemolysis interference specifications with reported biases up to -43.6 % UIBC when hemolyzed serum samples contained 200 mg/dL hemoglobin.
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-2264-2025. 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.