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The Food and Drug Administration is warning consumers not to use pregnancy, UTI, and ovulation tests manufactured by Universal Meditech, Inc.
The FDA said that the company "has stopped all operations and is no longer providing support for its tests."
"The FDA is not able to confirm the performance of UMI's tests, raising concerns that the tests may not be safe and effective," the agency said in a safety communication on Friday (August 11).
The FDA said the company issued a recall for unsold products but did not recall those already sold.
The recalled products were sold online by at least four distributors:
- AC&C Distribution, LLC.
- HealthyWiser
- Home Health US Inc.
- Prestige Biotech Inc.
The recalled 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
- PrestiBio Breast Milk Alcohol Test Strips
Consumers are advised to throw away the recalled tests immediately and get retested with another brand.