🔍 RecallPedia

V8 Immunodisplacement Kit REF 1803

Class I - Dangerous
🏥 Medical Devices Recalled: April 6, 2022 Helena Laboratories Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Model Number: 1803 UDI Codes: +M52518030/SS73-21-1803/14D20230831Z +M52518030/SS71-21-1803/14D20230830X Lot 3-21-1803 Lot 1-22-1803
  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:
Due to microbial growth causing interference with interpretation.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

V8 Immunodisplacement Kit REF 1803

Product Codes/Lot Numbers:

Model Number: 1803 UDI Codes: +M52518030/SS73-21-1803/14D20230831Z +M52518030/SS71-21-1803/14D20230830X Lot 3-21-1803 Lot 1-22-1803

Distribution:

Distributed in: FL, MO, OH, TX

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1244-2022

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