Celltrion DiaTrust COVID-19 Ag Rapid Test recall: Labeling Error
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…
Why was Celltrion DiaTrust COVID-19 Ag Rapid Test recalled?
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.
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?
All lots
- Product
- 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…
- Recalling firm
- CELLTRION USA INC
- Quantity
- 162,000 ea
- Distribution
- US Nationwide distribution in the state of CA.
- Recall date
- February 9, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)