FDA Issues Warning About Unsafe Pregnancy and UTI Tests Manufactured by Universal Meditech Inc.
CNN – The US Food and Drug Administration (FDA) issued a warning on Friday regarding certain tests manufactured by Universal Meditech Inc. (UMI), advising consumers not to use them. The tests in question include those used for pregnancy, ovulation, and urinary tract infections.
According to the FDA, UMI has informed them that it has ceased all operations and is no longer providing support for its tests. The agency expressed concerns about the safety and effectiveness of UMI’s tests and stated that it is unable to confirm their performance.
While UMI has recalled undistributed tests, those already in the hands of consumers have not been recalled. The FDA is urging consumers not to purchase or use the following Universal Meditech tests and to dispose of them immediately:
– 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
These tests may have been distributed under various brand names, such as AC&C, HealthyWiser, Home Health US, and Prestige Biotech.
The FDA recommends that individuals who have used any of these tests and still require results should perform the tests again using a different brand. If there are concerns regarding accuracy, it is advised to reach out to a healthcare provider.
Additionally, consumers who have experienced problems with these tests or devices are encouraged to report them to the FDA through its MedWatch program.
It is important for consumers to be cautious when it comes to purchasing and using medical tests. Ensuring that these tests are from reputable manufacturers is crucial for accurate results and the safety of individuals.