🔍 RecallPedia

Access Total T4 Calibrator, Catalog No. 33805

Class I - Dangerous
🏥 Medical Devices Recalled: March 16, 2026 Beckman Coulter Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI 15099590225872 Lots 538729, 538815, 538898, 539107, 539243
  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 has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. A false low patient result could cause a patient to undergo unnecessary additional diagnostic testing. A patient may be treated for a disorder not present or receive delayed treatment for hyperthyroidism. For a pregnant patient being monitored for thyroid hormone supplementation, incorrect treatment or dose may be used. A delayed patient results could cause repeat blood draw with associated complications.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Access Total T4 Calibrator, Catalog No. 33805

Product Codes/Lot Numbers:

UDI-DI 15099590225872 Lots 538729, 538815, 538898, 539107, 539243

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1922-2026

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