August 14, 2023 – The U.S. Food and Drug Administration (FDA) has issued a cautionary alert urging patients to refrain from using specific tests produced by Universal Meditech Inc. (UMI), including tests designed for pregnancy, ovulation, and detecting urinary tract infections.
UMI has informed the FDA that it has ceased all operations and no longer offers support for its tests. The FDA’s inability to verify the performance of UMI’s tests raises concerns about their safety and effectiveness.
While UMI recalled unsold tests from distributors, tests that were already sold to consumers have not been recalled, the FDA disclosed.
The following tests are flagged by the FDA as unfit for use:
- 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 were retailed online through various distributors, including AC&C Distribution LLC, HealthyWiser, Home Health US Inc., and Prestige Biotech Inc. Notably, the tests sold by these companies might not explicitly indicate that they were manufactured by UMI.
The FDA emphasizes that individuals who have acquired any of the listed tests should dispose of them.
In the event that you have utilized one of the recalled tests and still desire accurate results, the FDA suggests opting for a different test.
Source: WebMD News Brief