🔍 RecallPedia

OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA. Distributed by Theridiag, Cedex, France

Class I - Dangerous
🏥 Medical Devices Recalled: December 21, 2012 Hitachi Chemical Diagnostics Diagnostic Equipment

What Should You Do?

  1. Check if you have this product:
    Catalog number: 85035. Lot number 42K283626, expiration May 31, 2013.
  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:
Hitachi Chemical Diagnostics Inc
Reason for Recall:
There is no evidence that a visual inspection was performed on one tray of coverslips. Possibility of a low fill volume which could lead to a false negative results.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA. Distributed by Theridiag, Cedex, France

Product Codes/Lot Numbers:

Catalog number: 85035. Lot number 42K283626, expiration May 31, 2013.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0793-2013