Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Reported: March 9, 2022 Initiated: December 2, 2021 #Z-0680-2022
Product Description
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Reason for Recall
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.
Details
- Recalling Firm
- CELLTRION USA INC
- Units Affected
- 8080 kits originally distributed; 726 kits redistributed
- Distribution
- Distributed to TX.
- Location
- Jersey City, NJ
Frequently Asked Questions
What product was recalled? ▼
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02. Recalled by CELLTRION USA INC. Units affected: 8080 kits originally distributed; 726 kits redistributed.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 9, 2022. Severity: Critical. Recall number: Z-0680-2022.
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