🔍 RecallPedia

Alinity i Anti-TPO Reagent Kit, List Number 09P3521

Class I - Dangerous
🏥 Medical Devices Recalled: April 24, 2023 Abbott Ireland Limited Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI Number: (01)00380740153892(17)240720(10)46009FN00; List Number: 09P3521; Lot Number: 46009FN00; Expiration Date: 07/20/2024
  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:
Abbott Ireland Limited
Reason for Recall:
Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower fill volume than detailed in the Kit Contents section of the Instructions for Use (IFU).
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Alinity i Anti-TPO Reagent Kit, List Number 09P3521

Product Codes/Lot Numbers:

UDI Number: (01)00380740153892(17)240720(10)46009FN00; List Number: 09P3521; Lot Number: 46009FN00; Expiration Date: 07/20/2024

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1696-2023