Reported Aug 13, 2025 · Ongoing
UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,
Beckman Coulter Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
- UIBC (Unsaturated Iron Binding Capacity)
- REFOSR61205
- Lot codes and dates
- All Lots/(01)15099590011925
- Amount recalled
- 56,696 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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