NYSDA Publications

FDA Announces Recall of Celltrion USA POC DiaTrust COVID-19 Ag Rapid Tests

The United States Food and Drug Administration (FDA) has announced that Celltrion USA is recalling certain Point of Care (POC) DiaTrust COVID-19 Ag Rapid Tests because they may have been distributed to unauthorized users.  FDA notes that emergency use of these tests is limited to authorized laboratories and use of these tests in unauthorized settings (for example, customers without CLIA-certification) may present an increased risk of false results as the persons performing these tests may not have the qualifications or training to properly and safely administer them.  The FDA has identified this as a Class I recall, the most serious type of recall, because use of these devices may cause serious injuries, serious health consequences, or death.  To read the FDA announcement and summary of the recall of Celltrion USA POC DiaTrust COVID-19 Ag Rapid Tests, use the link below.