FDA
FDA warns against using tests manufactured by Universal Meditech
August 16, 2023

FDA warns consumers to not use the One Step Pregnancy Test and 14 other related tests manufactured by Universal Meditech, Inc. (UMI). FDA cannot confirm performance of these tests, raising concerns that the tests may not be safe and effective. UMI has stopped all operations and is no longer providing support for its tests. Tests have been sold online to consumers by at least four distributors: AC&C Distribution, LLC., HealthyWiser, Home Health US Inc., and Prestige Biotech Inc., but the tests may not have identified UMI as the manufacturer. Tap for more info on specific tests.
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