The Food and Drug Administration (FDA) has issued a safety communication regarding tests manufactured by Universal Meditech, Inc.
The Food and Drug Administration (FDA) has issued a safety communication regarding tests manufactured by Universal Meditech, Inc.The tests include One Step Pregnancy Test; DiagnosUS One Step Ovulation Test; HealthyWiser UriTest 10 Parameter Reagent Test Strips for Urinalysis; HealthyWiser UriTest UTI Test Strips; HealthyWiser KetoFast Ketone Test Strips; HealthyWiser pH-Aware pH Test Strips; To Life hCG Pregnancy Urine Test; Am I Pregnant Pregnancy Midstream Test; DeTec hCG Pregnancy Urine Test; PrestiBio Pregnancy Strips; PrestiBio Rapid Detection Pregnancy Test Midstream; PrestiBio Ovulation Strips; PrestiBio Urinalysis Test Strip 10 Parameters; PrestiBio Ketone Test Strips; and PrestiBio Breast Milk Alcohol Test Strips.
The tests were sold online by multiple distributors, including AC&C Distribution, LLC, HealthyWiser, Home Health US Inc, and Prestige Biotech Inc.
According to the FDA, these tests may not be safe and effective because Universal Meditech is no longer providing support for them. The Company has stopped all operations and has recalled undistributed tests from distributors; however, a recall of distributed tests has not been initiated.
In an effort to protect the public, the FDA is recommending that these tests not be purchased or used. Individuals who have used one of these tests should consider retesting with a different test or contacting a health care provider for additional guidance.
Adverse events and quality problems should be reported to the FDA’s MedWatch program.
This article originally appeared on MPR
US Food and Drug Administration. Do not use tests manufactured by Universal Meditech, Inc: FDA safety communication. Accessed August 11, 2023. Accessed August 14, 2023. https://www.fda.gov/medical-devices/safety-communications/do-not-use-tests-manufactured-universal-meditech-inc-fda-safety-communication.