Celltrion DiaTrust COVID-19 Ag Rapid Test recall
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Why was Celltrion DiaTrust COVID-19 Ag Rapid Test 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots COVGCCF0001, COVGCCF0002
- Product
- Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
- Recalling firm
- CELLTRION USA INC
- Quantity
- 8080 kits originally distributed; 726 kits redistributed
- Distribution
- Distributed to TX.
- Recall date
- March 9, 2022
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)