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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 28, 2021
Create Date March 02, 2022
Recall Status1 Open3, Classified
Recall Number Z-0659-2022
Recall Event ID 89508
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 Lot COVGCCM0008
Recalling Firm/
Manufacturer
CELLTRION USA INC
1 Evertrust Plz Ste 1207
Jersey City NJ 07302-3087
For Additional Information Contact Charlotte Jaeun Kang
201-988-4615
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
Under Investigation by firm
Action The 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 Commerce 243 kits (6,075 tests)
Distribution US distribution to CA, FL, NJ, NY, PA, SC.
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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