Beckman Coulter recalls UIBC assay kits that may not meet claimed hemoglobin interference specifications, potentially causing inaccurate results in low UIBC samples.
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.
Beckman Coulter is recalling UIBC assay kits that may not work correctly with hemoglobin levels up to 200 mg/dL. This could lead to inaccurate test results in certain blood samples.
The UIBC assay may not properly measure hemoglobin interference in samples with low UIBC levels. When hemolyzed serum samples contain 200 mg/dL hemoglobin, the test can show biases up to -43.6% UIBC, leading to inaccurate results.
Users of UIBC assay kits for blood testing who measure hemoglobin levels up to 200 mg/dL may be affected. Those testing samples with low UIBC levels are at higher risk of inaccurate results.
Check for the product name 'UIBC (Unsaturated Iron Binding Capacity)' with lot number (01)15099590011925. The recall covers all lots of this product.
Look for the lot number (01)15099590011925 on the UIBC assay kit packaging.
Beckman Coulter identified that the UIBC assay may not meet claimed hemoglobin interference specifications, potentially causing inaccurate results in samples with low UIBC levels.
The assay may show biases up to -43.6% UIBC when hemolyzed serum samples contain 200 mg/dL hemoglobin, leading to inaccurate results.
The recalled product is the UIBC (Unsaturated Iron Binding Capacity) assay with lot number (01)15099590011925.
We’ve drafted a message you can send Beckman Coul: Inc. to request your refund or repair — edit it as you like.
Subject: Recall Z-2264-2025 — Beckman Coul: Inc. Beckman Coul: Inc. Hello, I own a Beckman Coul: Inc. that is covered by recall Z-2264-2025 from Beckman Coul: Inc.. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
