The Food and Drug Administration has initiated an immediate recall for a range of pregnancy and ovulation tests.
On Friday, the agency announced that the tests were no longer safe. The Food and Drug Administration has stated that Universal Meditech, the manufacturer, has ceased support for the tests. This decision has raised concerns about the reliability and safety of these tests.
“UMI has notified the FDA that it has stopped all operations and is no longer providing support for its tests,” the agency said. “The FDA is not able to confirm the performance of UMI’s tests, raising concerns that the tests may not be safe and effective.”
Although Universal Meditech (UMI) took action to recall tests that had not yet been distributed to their distributors, they did not undertake a recall for tests that had already been given to consumers. In light of the Food and Drug Administration’s (FDA) apprehensions regarding these tests, the FDA is releasing this safety advisory to inform and protect the well-being of consumers and patients, aligning with its responsibility to safeguard public health.
Consumers are being advised by the FDA to refrain from using or buying the tests mentioned below. Furthermore, the FDA recommends discontinuing the use of and disposing of all recalled tests by discarding them in the trash.
- 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
