Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer, 25 filter caps, 25 sterilized swabs per box.
Class I - DangerousWhat Should You Do?
- Check if you have this product: All lots
- 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:
- CELLTRION USA INC
- Reason for Recall:
- The European version of the DiaTrust COVID-19 Ag Rapid Test is not approved for marketing in the U.S. but was illegally distributed in the U.S. The packaging and labeling of the European test kit is different from the US test kit and is NOT authorized for distribution in the US.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer, 25 filter caps, 25 sterilized swabs per box.
Product Codes/Lot Numbers:
All lots
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0558-2022
Related Recalls
Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID.
Kits were labeled with incorrect expiration dates.
The affected lot was placed under quarantine in September 2021 due to complaints of alleged false positives, but 243 kits were erroneously released to customers in December 2021.