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U.S. Department of Health and Human Services

Class 2 Device Recall Celltrion DiaTrustTM COVID19 Ag Rapid Test

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  Class 2 Device Recall Celltrion DiaTrustTM COVID19 Ag Rapid Test see related information
Date Initiated by Firm February 25, 2022
Date Posted March 08, 2022
Recall Status1 Open3, Classified
Recall Number Z-0731-2022
Recall Event ID 89640
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 Numbers: COVGCCM0006, COVGCCM0007, COVGCCM0008, COVGCCM1002, COVGCCM1003, COVGCCM1004, COVGCCM1005, COVGCCM1006, COVGCCM1007
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		 Kits were labeled with incorrect expiration dates.
FDA Determined
Cause 2		 Incorrect or no expiration date
Action An URGENT: MEDICAL DEVICE RECALL notification letter dated 2/25/22 was sent to customers. Immediate Actions to be taken by You: 1. Examine your inventory for affected product. Please identify the LOT number printed on the outer box to determine whether the products you received are from lots COVGCCM0006, COVGCCM0007, COVGCCM0008, COVGCCM1002, COVGCCM1003, COVGCCM1004, COVGCCM1005, COVGCCM1006 or COVGCCM1007. 2. If you identify kits from the lots above in your inventory, quarantine the products and do not use them. 3. If you identified kits with Lot Number COVGCCM0006, COVGCCM0007, COVGCCM0008, COVGCCM1002, COVGCCM1003, COVGCCM1004, COVGCCM1005, COVGCCM1006 or COVGCCM1007, please contact celltrionusa.CS@celltrion.com and Celltrion USA, Inc. will provide the shipping label for return to the address below. Celltrion USA, Inc. One Evertrust Plaza Suite 1207, Jersey City, New Jersey, 07302, USA 4. Please complete the enclosed Acknowledgement and Receipt Form with the information requested and return the form in accordance with the instructions on the form. Please complete this form even if you do not have the product on hand. For additional questions, please contact Celltrion USA by calling +1 (201) 320-2023 Monday through Friday, 9:00 AM to 6:00 PM or email to celltrionusa.CS@celltrion.com.
Quantity in Commerce 1,228,200 tests
Distribution The products were distributed to the following US states: CA, CT, FL, HI, MA, MT, NJ, NY, PA, TN, and 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 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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