🔍 RecallPedia

CMV IgM EIA, in vitro diagnostic.

Class I - Dangerous
🏥 Medical Devices Recalled: October 19, 2022 Bio-Rad Laboratories Diagnostic Equipment

What Should You Do?

  1. Check if you have this product:
    Catalog Number: 25178 UDI-DI Code: 00847865010733 Lot Numbers: B02022 E10022 G05022
  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:
Bio-Rad Laboratories, Inc.
Reason for Recall:
Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

CMV IgM EIA, in vitro diagnostic.

Product Codes/Lot Numbers:

Catalog Number: 25178 UDI-DI Code: 00847865010733 Lot Numbers: B02022 E10022 G05022

Distribution:

Distributed in: CA, CO, FL, GA, HI, IA, MA, MN, NC, NH, NJ, PA, TN, TX

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0342-2023

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