Celltrion USA Recalls Certain Point of Care Celltrion DiaTrust COVID-19 Ag Rapid Tests for False Positive Test Results and Unauthorized Shelf Life

Date: 03/23/2022

Product Type:  Medical Devices

Company Name: Celltrion DiaTrust COVID-19 Ag Rapid Test

Product Code: 83QKP

Lot Numbers:  See Recall Database Entry

Devices Recalled in the U.S.: 45,500

Distribution Dates:  June 2, 2021, to December 21, 2021

Date Initiated by Firm: February 28, 2022

USA-FDA Link: https://www.fda.gov/medical-devices/medical-device-recalls/celltrion-usa-recalls-certain-point-care-celltrion-diatrust-covid-19-ag-rapid-tests-false-positive