🔍 RecallPedia

Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850

Class I - Dangerous
🏥 Medical Devices Recalled: February 27, 2025 Beckman Coulter Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 15099590224301; Lot Number: 439850
  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 received complaints of erroneous Vitamin B12 results when using Access Vitamin B12 Reagent lot 439850. The affected reagent lot may cause erroneously low or high Vitamin B12 results, leading to a delayed or improper diagnosis and/or repeat testing.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850

Product Codes/Lot Numbers:

UDI-DI: 15099590224301; Lot Number: 439850

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2115-2025

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