Beckman Coulter Inc. Recall: UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,
Beckman Coulter Inc. Recall: UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205, is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Beckman Coulter Inc.; Product: UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,; Reason for recall: Beckman Coulter identified that the Unsatura
| Recalling firm | Beckman Coulter Inc. |
|---|---|
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | US: AK, AL, AR, CO, CT, DC, DE, ID, UT OUS: Algeria, Argentina, Australia, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, China, Colombia, Costa Rica, Croatia, Czechia, Egypt, El Salvador, Ethiopia, Georgia, Germany, Ghana, Gibraltar, Greece, Hong Kong, Hung |
| Recall initiated | 20250626 |
| Recall number | Z-2264-2025 |
| Category | device |
| State | CA |
| Country | United States |
$29/mo
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