Class 1 Device Recall Celltrion DiaTrust COVID19 Ag Rapid Test

• Date Initiated by Firm: December 02, 2021
• Date Posted: March 02, 2022
• Recall Status: Terminated on June 10, 2024
• 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: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.