Celltrion Point of Care COVID-19 Tests Recalled from Unauthorized Users

Serious injuries or death may result from the use of these devices. This is a Class I recall, the most serious type of recall.

If your email program has trouble displaying this email, view as a webpage. Celltrion USA Recalls Certain Point of Care DiaTrust COVID-19 Ag Rapid Test Kits Which May Have Been Distributed to Unauthorized, Non-CLIA-Certified Users Celltrion USA is recalling certain Point of Care (POC) DiaTrust COVID-19 Ag Rapid Tests because they may have been distributed to unauthorized users. 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. Use of these devices may cause serious injuries, serious health consequences, or death. Read More Questions? If you have questions about this recall, contact celltrionusa.CS@celltrion.com.

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