Recall Z-0659-2022— CELLTRION USA INC
Class I · Terminated
Class I FDA medical device recall by CELLTRION USA INC, initiated 2021-12-28, terminated 2024-06-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02. Reason: 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..
- Recalling firm
- CELLTRION USA INC
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2021-12-28
- Terminated
- 2024-06-10
- Firm location
- Jersey City, NJ, United States
Product description
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.