🔍 RecallPedia

Access Thyroglobulin Calibrators

Class I - Dangerous
🏥 Medical Devices Recalled: July 6, 2023 Beckman Coulter Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    UDI/DI 15099590227166, Serial/Lot Numbers: 233806, 234171, 234355, 234443, 234444, 234617, 337940
  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:
It has been determined through an internal investigation that the alternate Access Thyroglobulin calibrator cards for use with the Thyg reagent packs distributed in April 2023 will cause a decrease of approximately 11% in patient results.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Access Thyroglobulin Calibrators

Product Codes/Lot Numbers:

UDI/DI 15099590227166, Serial/Lot Numbers: 233806, 234171, 234355, 234443, 234444, 234617, 337940

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0100-2024

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