Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Numbers: 53K41T5T1 53K41X1T1 53K41X2T1 53K41X3T1 53K4211T1 53K4212T1 53K4213T1 53K4221T1 53K4222T1 53K4223T1 53K4224T1 53K4225T1 53K4231T1 53K4232T1 53K4233T1 53K4261T1 53K4262T1 53K4271T1 53K4272T1 53K4273T1 53K4274T1 53K4291T1 53K4292T1 53K42A1T1 53K42A2T1 53K42A3T1 53K42E1T1 53K42G1T1 53K42G2T1 53K42H1T1 53K42H2T1 53K42L1T1 53K42L2T1 53K4361AC 53K4362AC 53K4392AC 53K38N3T1 53K38N2T1 53K38N1T1 53K38N4T1 53K38N5T1 53K38P1T1 53K38P2T1 53K38P3T1
- 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:
- SD Biosensor, Inc.
- Reason for Recall:
- The liquid buffer component in the affected test kit lots was determined to have bacterial contamination. User may notice a slight odor when the buffer is brought close to the nose.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)
Product Codes/Lot Numbers:
Lot Numbers: 53K41T5T1 53K41X1T1 53K41X2T1 53K41X3T1 53K4211T1 53K4212T1 53K4213T1 53K4221T1 53K4222T1 53K4223T1 53K4224T1 53K4225T1 53K4231T1 53K4232T1 53K4233T1 53K4261T1 53K4262T1 53K4271T1 53K4272T1 53K4273T1 53K4274T1 53K4291T1 53K4292T1 53K42A1T1 53K42A2T1 53K42A3T1 53K42E1T1 53K42G1T1 53K42G2T1 53K42H1T1 53K42H2T1 53K42L1T1 53K42L2T1 53K4361AC 53K4362AC 53K4392AC 53K38N3T1 53K38N2T1 53K38N1T1 53K38N4T1 53K38N5T1 53K38P1T1 53K38P2T1 53K38P3T1
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1594-2023
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