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. The products were distributed to the following US states: CA, CT, FL, HI, MA, MT, NJ, NY, PA, TN, and TX.ġ A record in this database is created when a firm initiates a correction or removal action. Please complete this form even if you do not have the product on hand.įor 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 in Commerce Please complete the enclosed Acknowledgement and Receipt Form with the information requested and return the form in accordance with the instructions on the form. will provide the shipping label for return to the address below.Ĥ. If you identified kits with Lot Number COVGCCM0006, COVGCCM0007, COVGCCM0008, COVGCCM1002, COVGCCM1003, COVGCCM1004, COVGCCM1005, COVGCCM1006 or COVGCCM1007, please contact and Celltrion USA, Inc. If you identify kits from the lots above in your inventory, quarantine the products and do not use them.ģ. 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.Ģ. Examine your inventory for affected product. Kits were labeled with incorrect expiration dates.Īn URGENT: MEDICAL DEVICE RECALL notification letter dated 2/25/22 was sent to customers.ġ. Product Code QKPĬelltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. Class 2 Device Recall Celltrion DiaTrustTM COVID19 Ag Rapid TestĬoronavirus antigen detection test system.
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