FDA warns public against UMI home tests

Feds warns the public against 15 tests manufactured by Universal Meditech. Inc., saying they cannot confirm that tests work as well as citing concerns they may not be safe

Woman hand holding pregnancy test and result is not pregnant
Darren Fraser
Published August 15, 2023  • 
9:00 am

REEDLEY – The U.S. Food and Drug Administration (FDA) issued an advisory on Aug. 11, warning the public not to use 15 tests that were manufactured by Universal Meditech, Inc. (UMI), including pregnancy, urinary tract infection and ketone tests, amongst others.

According to the advisory, UMI notified the agency that it has stopped all operations and is no longer providing support for its tests, so “the FDA is not able to confirm the performance of UMI’s tests, raising concerns that the tests may not be safe and effective.” 

This announcement comes following the recent discovery of an illegally-operated UMI lab found in the city of Reedley. Not only that, but it comes roughly eight months after UMI initiated a nationwide recall of 56,300 of rapid test kits for COVID-19 – more specifically, the “Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits,” according to the FDA.

The tests that have been banned as of Aug. 11 are:

  • 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 were distributed by AC&C Distribution, LLC., HealthyWiser, Home Health  US Inc., and Prestige Biotech, Inc. According to the FDA, the above tests were distributed under the brand names of these companies and may not have listed UMI as the manufacturer.

Also according to the FDA, UMI did initiate a recall for tests that had not been distributed, but did not attempt to recall tests that had been distributed to the public. 

The FDA recommends consumers stop using the above tests and destroy them. Anyone who is experiencing or who has experienced an adverse reaction should contact the FDA’s MedWatch Adverse Event Reporting program.

Darren Fraser