Class 1 Device Recall Celltrion DiaTrust COVID19 Ag Rapid Test

• Date Initiated by Firm: April 01, 2022
• Date Posted: April 27, 2022
• Recall Status: Terminated on June 11, 2024
• 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: 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.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.