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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 April 01, 2022
Date Posted April 27, 2022
Recall Status1 Completed
Recall Number Z-0953-2022
Recall Event ID 89965
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 All lots distributed to end users without valid CLIA ID UPC: 8 806121 763044 Distributed from December 2021 through February 2022.
Recalling Firm/
Manufacturer		 CELLTRION USA INC
1 Evertrust Plz Ste 1207
Jersey City NJ 07302-3087
For Additional Information Contact Mr. BonJoong Kim
201-988-4615
Manufacturer Reason
for Recall		 Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID.
FDA Determined
Cause 2		 Other
Action On April 1, 2022, the firm notified distributors of the issue via letter, following up with meetings with each distributor on April 5, 2022 and emails on April 6, 2022. The firm instructed distributors to communicate the recall to their affected customers, down to the user level. Customers who do not have CLIA IDs must return the product to their distributors.
Quantity in Commerce 12,632 kits
Distribution US Nationwide distribution.
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.
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