QUIDEL Sofia SARS Antigen FIA IVD REF 20374
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model Number 20374 Lot Number: 706142 UPC A GTIN-12: 0 14613 33908 2 Cassettes: 168365 through 166817
- 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:
- Quidel Corporation
- Reason for Recall:
- Due to false positive results.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
QUIDEL Sofia SARS Antigen FIA IVD REF 20374
Product Codes/Lot Numbers:
Model Number 20374 Lot Number: 706142 UPC A GTIN-12: 0 14613 33908 2 Cassettes: 168365 through 166817
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0428-2021
Related Recalls
Dipstick strep A test has potential for false positive results.
There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test results, the positivite test line may not be visible/ hidden under the cassette of the test device thus potentially leading to a false negative result.
There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test results, the positivite test line may not be visible/ hidden under the cassette of the test device thus potentially leading to a false negative result.