🔍 RecallPedia

Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems

Class I - Dangerous
🏥 Medical Devices Recalled: January 2, 2025 Beckman Coulter Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI 15099590736002 Lots 339062, 439811
  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:
Identified reagent lots are experiencing a high rate of calibration failures with failure code of "Max Iterate" on Access 2 and UniCel Dxl Immunoassay Systems. Reporting of results may be delayed due to the time required to achieve a passing calibration curve.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems

Product Codes/Lot Numbers:

UDI-DI 15099590736002 Lots 339062, 439811

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1112-2025

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Class I - Dangerous

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