The Food and Drug Administration said to stop using and destroy recalled tests.
Recalled tests include:
- 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
Universal Meditech, Inc. reportedly notified the FDA that it stopped all operations and is no longer providing support for its tests. The FDA is not able to confirm at this time the performance of UMI’s tests, causing the FDA to raise concerns that the tests may not be safe or effective.
According to the FDA, the tests were distributed under brand names and may not have identified UMI as a manufacturer. The tests may also have been distributed by other distributors, according to the FDA.
While UMI initiated a recall to remove undistributed tests from their distributors, they did not initiate a recall for tests that were already distributed to consumers.
If you use one of these tests and still want a result, the FDA said to test again with a different test. The FDA recommends talking to a healthcare provider with concerns about test-result accuracy.
The FDA is encouraging those who experience adverse events or quality problems with the tests to report them to the FDA’s MedWatch Adverse Event Reporting Problem.
The FDA is continuing to monitor this situation.