NEW YORK – The US Food and Drug Administration issued a warning Friday against the use of a slate of pregnancy and women's health tests made by Universal Meditech.
Universal Meditech told FDA officials the firm has halted all operations, and it will no longer provide support for its tests, resulting in the agency saying it has concerns the tests may not be safe and effective. The firm recalled tests from its distributors but did not recall tests already distributed to consumers.
The agency also warned that the tests were distributed under the brand names of its distributors AC&A Distribution, HealthyWiser, Home Health US, and Prestige Biotech, and the test packaging may not indicate that the products were made by Universal Meditech.
FDA officials identified 15 affected products made by Universal Meditech, six of which are pregnancy tests. The affected pregnancy tests are the One Step Pregnancy Test, To Life hCG Pregnancy Urine Test, Am I Pregnant Urine Test, DeTec hCG Pregnancy Urine Test, PrestiBio Pregnancy Strips, and PrestiBio Rapid Detection Pregnancy Test Midstream. The other affected tests are the firm's 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, PrestiBio Ovulation Strips, PrestiBio Urinalysis Test Strip 10 Parameters, PrestiBio Ketone Test Strips, and PrestiBio Breast Milk Alcohol Test Strips.
The agency said any of these tests should be disposed of as trash and any tests performed with these products should be repeated with tests from other manufacturers.