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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 Testsee related information
Date Initiated by FirmDecember 28, 2021
Date PostedMarch 02, 2022
Recall Status1 Terminated 3 on June 10, 2024
Recall NumberZ-0659-2022
Recall Event ID 89508
Product Classification Coronavirus antigen detection test system. - Product Code QKP
ProductCelltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Code Information Lot COVGCCM0008
Recalling Firm/
Manufacturer		 CELLTRION USA INC
1 Evertrust Plz Ste 1207
Jersey City NJ 07302-3087
For Additional Information ContactDennis Seungryum Kim
551-655-9338
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Process control
ActionThe firm initially placed a hold on product due to complaints of false positive and false negative results in September 2021. After product was erroneously distributed from this lot in December 2021, the firm notified affected customers that the lot should not have been distributed and should not be used. This email went out on or around December 28, 2021. Customers were instructed to NOT use the affected lot.
Quantity in Commerce243 kits (6,075 tests)
DistributionUS distribution to CA, FL, NJ, NY, PA, SC.
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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