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Do Not Use Tests Manufactured by Universal Meditech Inc. - FDA Safety Communication
Today, 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 FDA that it has stopped all operations and is no longer providing support for its tests. The FDA is unable to confirm the performance of these tests, raising concerns that the tests may not be safe and effective.
Questions?
If you have questions about this safety communication, contact the Division of Industry and Consumer Education (DICE).
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