🔍 RecallPedia

Apo B Reagent, REF: OSR6143

Class I - Dangerous
🏥 Medical Devices Recalled: April 23, 2025 Beckman Coulter Ireland Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot # 2631/UDI: 15099590010409
  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 Ireland, Inc.
Reason for Recall:
The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B patient result which could exceed the total allowable error for the APO B assay (11.6%). The error results in results with a positive bias up to 42%. However, based on the mitigating factors the risk to health is considered to be negligible or limited.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Apo B Reagent, REF: OSR6143

Product Codes/Lot Numbers:

Lot # 2631/UDI: 15099590010409

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1815-2025