Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Celltrion DiaTrust COVID19 Ag Rapid Test

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Celltrion DiaTrust COVID19 Ag Rapid Test see related information
Date Initiated by Firm December 01, 2021
Create Date February 03, 2022
Recall Status1 Open3, Classified
Recall Number Z-0558-2022
Recall Event ID 89455
Product Classification Coronavirus antigen detection test system. - Product Code QKP
Product Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer, 25 filter caps, 25 sterilized swabs per box.
Code Information All lots
Recalling Firm/
Manufacturer		 CELLTRION USA INC
1 Evertrust Plz Ste 1207
Jersey City NJ 07302-3087
Manufacturer Reason
for Recall		 The European version of the DiaTrust COVID-19 Ag Rapid Test is not approved for marketing in the U.S. but was illegally distributed in the U.S. The packaging and labeling of the European test kit is different from the US test kit and is NOT authorized for distribution in the US.
FDA Determined
Cause 2		 No Marketing Application
Action Celltrion Healthcare informs Celltrion USA on 2021-11-11 that it had sent cease and desist letter to distributors who were illegally distributing non-EUA product in the U.S. Celltrion demanded return of all EU product from distributors' inventory and demanded removal of all EU DiaTrustTests from the U.S. In addition, the firm sent letters to all EU distributors warning against diversion and obtaining confirmation that distributors understand limitations on distribution only within the EU.
Quantity in Commerce 162,000 ea
Distribution US Nationwide distribution in the state of CA.
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.
-
-