Laboratories should be aware of news from the FDA about problems with COVID-19 tests and some prenatal screening tests, along with recommendations from the USDA on dangerous avian flu.
Laboratories should be aware of news from the FDA about problems with COVID-19 tests and some prenatal screening tests, along with recommendations from the USDA on dangerous avian flu.
Counterfeit COVID-19 Self-Tests
The U.S. Food and Drug Administration (FDA) has recently published a website about counterfeit COVID-19 self-tests. Counterfeit versions of the following COVID-19 self-tests are being used and distributed in the United States:
The FDA has not authorized, cleared, or approved these tests for use or distribution in the United States, but the tests are made to look like FDA-authorized tests so users will think they are legitimate. The FDA is concerned about the risk of false results when people use these counterfeit tests.
Celltrion DiaTrust™ COVID-19 Ag Rapid Test Kits Recalled
Celltrion USA recently recalled certain point-of-care DiaTrust™ COVID-19 Ag Rapid Test Kits because these test kits may have been distributed to unauthorized users who are not CLIA-certified.
The USDA identifies this as a Class 1 recall, the most serious type of recall.
False Results with Genetic Non-Invasive Prenatal Screening Tests
On April 19, 2022, the FDA issued a safety communication about the risk of false results with genetic non-invasive prenatal screening (NIPS) tests, sometimes called noninvasive prenatal testing or tests (NIPT).
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