Pregnancy Test Kit Recall Issued Due to Lack of Effectiveness, Leading FDA To Issue “Do Not Use” Warning

Officials have identified at least four distributors that have continued to sell recalled pregnancy, ovulation and urinary tract infection (UTI) test kits.

Federal health authorities are warning individuals to stop using certain pregnancy, ovulation and UTI test kits, which were previously recalled due to efficacy failures, but appear to still be available for sale.

The U.S. Food and Drug Administration (FDA) issued a Universal Meditech pregnancy test kit warning on August 11, stating that multiple distributors continue to offer 15 brands of pregnancy, ovulation and UTI test kits for sale online, even though they are known to have accuracy problems.

The warning states consumers may not be aware that the products were previously recalled because the tests were distributed under the brand names of the distributors, and may not list Universal Meditech Inc. as the manufacturer.

Universal Meditech issued a recall of their undistributed pregnancy, ovulation, and urinary tract infection detection tests due to lack of effectiveness. However, the manufacturer only recalled those kits which had not yet been distributed. Therefore, some tests were not removed from the consumer market and continue to be available for purchase.

The tests continue to be available for purchase online by AC&C Distribution, LLC, HealthyWiser, Home Health US Inc., and Prestige Biotech Inc., according to the warning. The FDA warns that consumers may inadvertently purchase an ineffective test online, which may provide inaccurate results.

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The FDA warning indicates the following tests manufactured by Universal Meditech Inc. may not be safe or effective:

  • 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 FDA recommends consumers use an alternative test or visit their health care provider to ensure accurate results. They also urge consumers to report any incidents or quality issues they experienced with the tests to the MedWatch Adverse Event Reporting program using the online reporting form.

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