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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.
Questions?
If you have questions about this recall, contact celltrionusa.CS@celltrion.com.
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