FDA Warning on 15 Universal Meditech Tests
FDA has issued a warning to not use 15 tests manufactured by Reno, CA-based Universal Meditech after the company notified the agency that it has stopped all operations and is no longer providing support for its tests. An FDA notice says it is not able to confirm the performance of UMI’s tests, raising concerns that the tests may not be safe or effective. Affected tests are:
- 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