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U.S. Department of Health and Human Services

Class 1 Device Recall Celltrion DiaTrust COVID19 Ag Rapid Test

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  Class 1 Device Recall Celltrion DiaTrust COVID19 Ag Rapid Test see related information
Date Initiated by Firm December 02, 2021
Create Date March 02, 2022
Recall Status1 Open3, Classified
Recall Number Z-0680-2022
Recall Event ID 89516
Product Classification Coronavirus antigen detection test system. - Product Code QKP
Product Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Code Information Lots COVGCCF0001, COVGCCF0002
Recalling Firm/
Manufacturer
CELLTRION USA INC
1 Evertrust Plz Ste 1207
Jersey City NJ 07302-3087
Manufacturer 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.
FDA Determined
Cause 2
Employee error
Action On December 2, 2021, the firm notified the affected distributor that the two lots are Research Use Only and should not be used. The distributor then notified the customer. Customer reported all product had been used.
Quantity in Commerce 8080 kits originally distributed; 726 kits redistributed
Distribution Distributed to TX.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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