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FDA warns against use of certain pregnancy, ovulation tests

FDA warns against use of certain pregnancy, ovulation tests

The Food and Drug Administration has issued an urgent recall for a set of pregnancy and ovulation tests the agency said it can no longer guarantee are safe.

Manufacturer Universal Meditech has stopped supporting the tests, the FDA said, bringing their reliability and safety into question. The company issued its own recall for remaining stock at distributors, but not for those already sold.

The affected brands of tests — which includes tests for pregnancy, ovulation and urine samples —  are the following:

  • 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 may have been distributed under brands including AC&C, HealthyWiser, Home Health US and Prestige Biotech. 

The FDA recommends people do not purchase or use these tests, destroy any they may possess and report quality issues to the agency.

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