The U.S. Food and Drug Administration (FDA) is warning consumers and patients to not use the following tests manufactured by Universal Meditech, Inc. (UMI):
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
UMI has notified the FDA that it has stopped all operations and is no longer providing support for its tests. The FDA is not able to confirm the performance of UMI’s tests, raising concerns that the tests may not be safe and effective.
Tests have been sold online to consumers by at least four distributors:
AC&C Distribution, LLC.
HealthyWiser
Home Health US Inc.
Prestige Biotech Inc.
These tests were distributed under the brand names of those distributors, and tests may not have identified UMI as the manufacturer. These tests may also have been distributed by other distributors.
