🔍 RecallPedia

biokitHSV-2 Rapid Test, REF: 300028001

Class I - Dangerous
🏥 Medical Devices Recalled: September 28, 2022 Biokit, S.A. Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI/Lots - Expiration Dates: 08426951056439/ B34243 - 2022-09-30, B34309 - 2022-11-30, B34463 - 2022-11-30, B34465 - 2023-02-28, B35052 - 2023-05-31, B35188 - 2023-07-31, B35398 - 2023-10-31
  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:
Biokit, S.A.
Reason for Recall:
HSV-2 rapid test may report false positive results.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

biokitHSV-2 Rapid Test, REF: 300028001

Product Codes/Lot Numbers:

UDI-DI/Lots - Expiration Dates: 08426951056439/ B34243 - 2022-09-30, B34309 - 2022-11-30, B34463 - 2022-11-30, B34465 - 2023-02-28, B35052 - 2023-05-31, B35188 - 2023-07-31, B35398 - 2023-10-31

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1021-2023