🔍 RecallPedia

Access Testosterone assay, Catalog Number 33560

Class I - Dangerous
🏥 Medical Devices Recalled: May 5, 2025 Beckman Coulter Diagnostic Equipment

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 15099590231347; Serial Number: 538081
  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:
Inadequate preventative maintenance (PM) performed on the scales of the RPL5 fill line, led to splashing (cross-contamination) between the wells of testosterone reagent packs lot 538081, which could potentially result in up to a 34% increase or a 23% decrease 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 Testosterone assay, Catalog Number 33560

Product Codes/Lot Numbers:

UDI-DI: 15099590231347; Serial Number: 538081

Distribution:

Distributed in: US, FL

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1901-2025

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