FDA warns certain pregnancy, ovulation, UTI tests may not be safe or effective

ByKatherine Dillinger, CNN, CNNWire
Tuesday, August 15, 2023
FDA warns certain pregnancy tests may not be safe or effective
Consumers shouldn't use certain pregnancy, ovulation or UTI tests manufactured by Universal Meditech Inc., the FDA warned.

Consumers shouldn't use certain tests manufactured by Universal Meditech Inc., the US Food and Drug Administration warned Friday, including those that test for pregnancy, ovulation and urinary tract infections.

"UMI has notified the FDA that it has stopped all operations and is no longer providing support for its tests," the agency said. "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 California-based company has recalled undistributed tests but not those that have already been distributed to consumers.

Consumers are advised not to purchase or use the following Universal Meditech tests but rather to throw them away:

  • 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

The tests may have been distributed under brand names such as AC&C, HealthyWiser, Home Health US and Prestige Biotech.

Anyone who has used one of these tests and still wants results should test again with a different brand and reach out to a health care provider if they have concerns about accuracy.

Consumers may report problems with devices or tests to the FDA through its MedWatch program.

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