🔍 RecallPedia

Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked

Class I - Dangerous
🏥 Medical Devices Recalled: January 9, 2022 Acon Biotech (Hangzhou) Co. Diagnostic Equipment

What Should You Do?

  1. Check if you have this product:
    Lots: COV1080201, COV1105014
  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:
Acon Biotech (Hangzhou) Co., Ltd.
Reason for Recall:
Non-EUA authorized, CE marked, SARS-CoV-2 antigen rapid test kits are being recalled from the U.S. market because use may lead to inaccurate test results, including false negative or false positive test results.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked

Product Codes/Lot Numbers:

Lots: COV1080201, COV1105014

Distribution:

Distributed in: US, MD, PA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0945-2022