Don’t Use Some Tests Made by Universal Meditech, FDA Warns

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Aug. 14, 2023 -- The U.S. Food and Drug Administration is warning patients not to use certain tests made by Universal Meditech Inc. (UMI), including tests 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 FDA 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 company recalled unsold tests from distributors but didn’t recall tests that were sold to consumers, the FDA said.

The FDA said consumers should not use these 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

Tests have been sold online by at least four distributors – AC&C Distribution LLC, HealthyWiser, Home Health US Inc., and Prestige Biotech Inc. The FDA said tests distributed by those companies may not be identified as being manufactured by UMI.

The FDA said people who purchased one of the tests should throw it away.

“If you used one of the recalled tests and still want results from such a test, test again using a different test,” the FDA said.