UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,
Class I - DangerousWhat Should You Do?
- Check if you have this product: All Lots/(01)15099590011925
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Beckman Coulter Inc.
- 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 I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,
Product Codes/Lot Numbers:
All Lots/(01)15099590011925
Distribution:
Distributed in: US, AK, AL, AR, CO, CT, DC, DE, ID, UT
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2264-2025
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