FDA Watch - Certain Celltrion DiaTrust COVID-19 Ag Rapid Tests by Celltrion USA:

Class I Recall - Due to False Positive Test Results and Unauthorized Shelf Life

If your email program has trouble displaying this email, view as a webpage. MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Certain Celltrion DiaTrust COVID-19 Ag Rapid Tests by Celltrion USA: Class I Recall - Due to False Positive Test Results and Unauthorized Shelf Life AUDIENCE: Patient, Health Professional ISSUE: Celltrion USA is recalling specific lots of the DiaTrust COVID-19 Ag Rapid Test due to a high number of false positive reports. A false-positive antigen test result may lead to a delay in both the correct diagnosis and treatment for the actual cause of a person's illness. False-positive results could also lead to more spread of the SARS-CoV-2 virus if presumed positive people are housed together. Additionally, the tests' labeling for the affected products includes a shelf life of 18 months. However, the FDA's emergency use authorization specifies these tests may only be used for 12 months.  The use of the affected product could cause serious adverse health consequences and death.  Although there have been no reports of injuries, adverse health consequences or death associated with the use of the affected products, false positive or false negative results from improper use of these tests could lead to further exposure of uninfected individuals to SARS-CoV-2 virus. There are also serious injury risks if someone who is not trained to collect a nasopharyngeal swab sample attempts to do so.  For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: The Celltrion DiaTrust COVID-19 Ag Rapid Test is intended to detect the presence of SARS-CoV-2, the virus that causes COVID-19, based on a nasopharyngeal (deep inside the nose to the back of the throat) swab sample from patients. The sample is collected by healthcare providers. RECOMMENDATIONS: On February 28, 2022 Celltrion USA sent letters to some affected distributors and customers with the following instructions:  Discontinue use Return all unused product Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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