FDA Warns Against Using Certain Pregnancy, Ovulation, UTI Tests

FRESNO, CA — Federal safety regulators are warning against using numerous pregnancy, ovulation and UTI tests made by Universal Meditech, which they said has stopped operating and is no longer supporting the tests.

The U.S. Food and Drug Administration issued the safety warning Friday, saying it couldn't confirm the performance of the Fresno-based company's tests, "raising concerns that the tests may not be safe and effective."

The following tests are included in the advisory:

• 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

The tests were sold online by at least four distributors:

• AC&C Distribution.
• HealthyWiser
• Home Health US Inc.
• Prestige Biotech Inc.

"These tests were distributed under the brand names of those distributors, and tests may not have identified UMI as the manufacturer," the FDA said. "These tests may also have been distributed by other distributors."

UMI initiated a recall to remove undistributed tests from their distributors, but the company did not recall tests that were already sold, the FDA said.

"Given 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 added.

Consumers and patients should not buy the tests. If already bought, consumers should stop using them and throw them out.

"If you used one of the recalled tests and still want results from such a test, test again using a different test and consider discussing with a health care provider if you have concerns about the accuracy of your test results," the FDA recommended.

Anyone who experiences any adverse events or quality problems with the tests should report as such to the FDA's MedWatch Adverse Event Reporting program.