FDA issues warning about faulty tests for pregnancy, sexually transmitted infections

The Food and Drug Administration is advising customers not to use certain brands of pregnancy, ovulation and urinary tract infection tests after the manufacturer found they were faulty.

Universal Meditech Inc., which makes various medical testing kits, said Friday that at least 15 of its tests could be ineffective.

The company has issued a recall for all unpurchased kits still in stores but has not done so for already purchased kits. Customers could have bought the kits online or in stores through distributors such as AC&C, Prestige Biotech or Home Health US.



The FDA has warned customers who purchased the recalled tests to throw them away and immediately retest with a different brand to confirm their findings.

“Given the FDA’s concerns about these tests, the FDA is issuing this safety communication to consumers and patients as part of its mandate to protect the public health,” the FDA said in a statement.

The full list of recalled tests is listed below:

• 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