• Posted August 14, 2023

Don't Use Certain Tests for Pregnancy, Ovulation, UTIs, FDA Warns

The U.S. Food and Drug Administration has warned that consumers should not use certain pregnancy, ovulation, urine, UTI and breast milk test kits over concerns that the tests may not be safe and effective.

The tests in question were manufactured by Universal Meditech Inc. (UMI), though they were branded under several names and may not include information about UMI on their packaging, the agency said in a news release.

The known distributors are AC&C Distribution LLC; HealthyWiser; Home Health US Inc. and Prestige Biotech Inc. The tests were sold under those brand names. UMI has notified the FDA that it has stopped all operations and is no longer providing support for its tests, the agency added.

The FDA could not confirm the performance of the company's tests, which were sold online by at least these four distributors. The tests may also have been sold under other brand names by other distributors.

UMI recalled undistributed tests, but did not seek to recall tests that were already purchased.

Some of the names the tests were sold under 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

Consumers should not use or purchase these tests, the FDA said. They should immediately stop using and throw out these tests.

Someone who used one of these tests and still wants results can 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 said.

Report any adverse events or quality problems experienced with the use of these tests to the FDA's MedWatch Adverse Event Reporting program.

More information

The National Library of Medicine has more on pregnancy tests.

SOURCE: U.S. Food and Drug Administration, news release, Aug. 11, 2023