AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit, RAPID TEST DEVICE, Whole Blood/Serum/Plasma, SKY Medical Supplies and Equipments, LLC.
Class I - Dangerous 🏥 Medical Devices
Recalled: January 19, 2021 Sky Medical Supplies and Equipments Diagnostic Equipment
Nationwide
What Should You Do?
- Check if you have this product: 2020042901
- 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:
- Sky Medical Supplies and Equipments LLC
- Reason for Recall:
- Distributed COVID test kits without emergency use authorization.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- completed
Product Information
Full Description:
AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit, RAPID TEST DEVICE, Whole Blood/Serum/Plasma, SKY Medical Supplies and Equipments, LLC.
Product Codes/Lot Numbers:
2020042901
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1127-2021