🔍 RecallPedia

UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,

Class I - Dangerous
🏥 Medical Devices Recalled: June 26, 2025 Beckman Coulter Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    All Lots/(01)15099590011925
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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.gov

FDA Recall Number: Z-2264-2025

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