FDAClass IMarch 9, 2022

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?

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.

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?

Lot COVGCCM0008

Product
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Recalling firm
CELLTRION USA INC
Quantity
243 kits (6,075 tests)
Distribution
US distribution to CA, FL, NJ, NY, PA, SC.
Recall date
March 9, 2022
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls