🔍 RecallPedia

SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.

Class I - Dangerous
🏥 Medical Devices Recalled: July 21, 2017 Helena Laboratories Diagnostic Equipment

What Should You Do?

  1. Check if you have this product:
    Lot 35-17-552583, exp. date 4/30/2018
  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:
Helena Laboratories, Corp.
Reason for Recall:
The plates do not have wells punched for the controls in the patient 1 area.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.

Product Codes/Lot Numbers:

Lot 35-17-552583, exp. date 4/30/2018

Distribution:

Distributed in: IN, KY, MA, OH, OR, TN, TX

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0045-2020

Related Recalls