Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot COVGCCM0008
- 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 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.
- 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, Reference No. CT-P60 D-2 02
Product Codes/Lot Numbers:
Lot COVGCCM0008
Distribution:
Distributed in: US, CA, FL, NJ, NY, PA, SC
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0659-2022
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.
Returned test kits were erroneously shipped to customers. The kits are intended for Research Use Only (RUO). Additional RUO test kits were shipped to customers unlikely to use them for RUO purposes, and the firm provided a letter assuring distributors that RUO tests could be used for clinical diagnosis.