(NewsNation) — The Food and Drug Administration is warning people not to use pregnancy, ovulation or urinary tract infection tests made by Universal Meditech, Inc.
The company alerted the FDA it was no longer supporting the tests and has stopped all operations. Tests were recalled from distributors, but the company did not issue a recall for tests already purchased by consumers.
“This company essentially went out of business so the FDA can’t test these tests,” Dr. Sujatha Reddy explained.
The tests may not say they were manufactured by Universal Meditech and were distributed under a number of brand names.
Because the FDA cannot guarantee the safety or accuracy of the tests, they are recommending consumers not use and throw away any of the following:
- 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
Reddy said the tests aren’t likely to cause harm to anyone, but the safety concern comes if people rely on the tests to know if they are pregnant or have an infection.
“It might be dangerous if you ignore your symptoms,” she said.
The agency also suggests anyone who used one of the tests should re-test with a different brand. People who believe they had a problem with the test being faulty can report it to the FDA through the MedWatch voluntary reporting form.
Regardless of what home tests you use, Reddy advises patients to always follow up with a doctor.
“I think it’s an option, but I would not rely on it 100%,” Reddy said.
