FDA warns public not to use certain pregnancy tests due to safety, accuracy issues
The U.S. Food and Drug Administration (FDA) has issued a warning urging consumers not to use certain tests produced by Universal Meditech (UM). The agency's safety communication underscores potential risks associated with multiple UM tests, highlighting questions surrounding their accuracy and safety.
UM manufactured a range of tests catering to different needs, including pregnancy, ovulation, urinalysis, ketone, and pH tests. These tests were distributed by online platforms and marketed under various brand names by different distributors. A total of 15 different products were flagged as part of the FDA safety warning:
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
PrestiBio Breast Milk Alcohol Test Strips
Distributors specifically mentioned in the FDA’s warning include AC&C Distribution, HealthyWiser, Home Health US and Prestige Biotech.
In response, UM has notified the FDA that it has ceased operations and will no longer distribute any tests. This cessation has prompted concerns within the FDA regarding the reliability of UM's products, as the agency cannot confirm their performance.
The FDA advises consumers not to use or purchase the identified tests, and to discontinue using any tests already obtained. For those seeking accurate results, the FDA suggests using alternative tests. Any issues with these tests should be reported to the FDA's MedWatch Adverse Event Reporting program.
The full safety communication can be found here.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.