STATEWIDE — The Food and Drug administration has recalled several products testing for pregnancy, UTI’s, and a variety of other conditions after deeming them “unsafe”.
Source: Sarah Silbiger / Getty
Universal Meditech Unlimited, a manufacturer of these products has stopped operations and have not announced the reason for halting production as of this writing. The FDA said in a statement that they cannot confirm the performance of UMI’s tests, which raised concerns about their effectiveness and safety. The list of recalled products includes:
– 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
Tests have been sold online to consumers by at least four distributors:
– AC&C Distribution, LLC.
– HealthyWiser
– Home Health US Inc.
– Prestige Biotech Inc.
In their statement the FDA included a list of steps to take following the recall including, not to use or purchase the tests listed above.
First, Immediately stop using and destroy these recalled tests by placing them in the trash. Test again using a different test and consider discuss with your health care provider if you have concerns about the accuracy of the test results, and to report any adverse events or quality problems experienced with the use of these tests to the FDA’s MedWatch Adverse Event Reporting program.
