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FDA Warns Against Using These Pregnancy, Ovulation and UTI Tests

The safety and effectiveness of various tests made by Universal Meditech have been called into question. See what specific tests are affected by the recall here.
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By Wyndi Kappes, Associate Editor
Published August 15, 2023
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Image: Tarasov_vl | Getty Images

There are plenty of things to worry about on your path toward parenthood, but finding a pregnancy or ovulation test, you can count on shouldn’t be one of them.

The Food and Drug Administration (FDA) issued a safety communication on August 11 asking consumers not to use a variety of tests manufactured by Universal Meditch (UMI). "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 organization said in a press release.

Ranging from pregnancy tests to ovulation strips and even breast milk alcohol test strips, the FDA is warning consumers not to use the following UMI tests:

  • 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

While UMI has stopped making tests and has initiated a recall to remove undistributed tests, the company did not initiate a recall for tests that were already distributed to consumers. Given the potential for these tests to render false results, the FDA found it necessary to issue a safety communication to the public.

The FDA recommends that consumers refrain from buying the tests listed above and discard any recalled tests. You can learn more about the recall and the FDA’s actions at FDA.gov.

Looking for a reliable pregnancy test? Check out these eight medically-reviewed and approved brands. In need of an ovulation test instead? Consider these ovulation predictor kits tested to help you find your fertile days.

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