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FDA Advises Against Using Universal Meditech's Pregnancy and Ovulation Tests

The Food and Drug Administration has urgently recalled a set of pregnancy and ovulation tests because the government can no longer vouch for their safety.

The FDA stated that the tests' validity and safety are doubtful since the manufacturer Universal Meditech Inc., (UMI) no longer supports them. The corporation only announced a recall for distributor stock that had yet to be distributed.

The following test manufacturers, which include those for pregnancy, ovulation, and urine samples, are affected:

  • 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

Customers may order tests online from at least four distributors, including AC&C Distribution, LLC, HealthyWiser, Home Health US Inc., and Prestige Biotech Inc.

Because they were marketed under the brands of those wholesalers, these tests may not have shown UMI as the producer. These tests could have been offered by other companies as well. UMI did not initiate a recall for tests that had already been made accessible, even though it ordered the removal of tests that its distributors had not yet delivered to consumers.

As part of its mission to safeguard the public's health, the FDA has expressed concerns about these tests and releasing this safety communication to consumers and patients.

The hormone that is found in all pregnancy tests is called human chorionic gonadotrophin (hCG), and it starts to be produced about six days after fertilization. Most pregnancy tests are packaged in a box with one or two long sticks, and the urine put on the stick will eventually appear there.

The FDA advises being cautious and avoiding using or getting the the above-mentioned tests. Individuals should also stop using these Meditech recalled tests immediately and throw them away in the garbage.

If needed, one should test again using a different test and think about talking to a healthcare practitioner. The agency also recommends informing the FDA's MedWatch Adverse Event Reporting program of any adverse events or quality issues encountered while using these tests.


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