Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for the qualitative detection of antigen SARS-CoV-2 in clinical samples (nasal swab).
Class I - Dangerous 🏥 Medical Devices
Recalled: April 26, 2021 LEPU MEDICAL TECHNOLOGY (BEIJING) CO. Diagnostic Equipment
What Should You Do?
- Check if you have this product: All Lots distributed within the U.S.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD
- Reason for Recall:
- Antigen Rapid Test Kit is not authorized, cleared, or approved for marketing and/or distribution in the U.S.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- completed
Product Information
Full Description:
Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for the qualitative detection of antigen SARS-CoV-2 in clinical samples (nasal swab).
Product Codes/Lot Numbers:
All Lots distributed within the U.S.
Distribution:
Distributed in: US, FL, IL, NY, GA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1620-2021
Related Recalls
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