Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
UIBC (Unsaturated Iron Binding Capacity) Recalled by Beckman Coulter Inc. Due to Beckman Coulter identified that the Unsaturated Iron Binding...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Beckman Coulter Inc. directly.
Affected Products
UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,
Quantity: 56,696 units
Why Was This 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.
Where Was This Sold?
This product was distributed to 9 states: AL, AK, AR, CO, CT, DE, ID, UT, DC
About Beckman Coulter Inc.
Beckman Coulter Inc. has 241 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report