Do not use tests manufactured by Universal Meditech, Inc.: FDA safety communication

Aug. 14, 2023
FDA update.

The U.S. Food and Drug Administration (FDA) is warning consumers and patients to not use the following tests manufactured by Universal Meditech, Inc. (UMI):

  • 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

UMI has notified the FDA that it 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. 

Tests have been sold online to consumers by at least four distributors:

  • AC&C Distribution, LLC.
  • HealthyWiser
  • Home Health US Inc.
  • Prestige Biotech Inc.

These tests were distributed under the brand names of those distributors, and tests may not have identified UMI as the manufacturer. These tests may also have been distributed by other distributors.

FDA release