FDA warns against using certain at-home pregnancy, ovulation, UTI tests

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(NEW YORK) -- The U.S. Food and Drug Administration is warning consumers not to use certain pregnancy, ovulation and urinary tract infection tests.

At least 15 tests manufactured by Universal Meditech Inc. (UMI) may be ineffective, including One Step Pregnancy Test, DiagnosUS One Step Ovulation Test, HealthyWiser UriTest UTI Test Strips and PrestiBio Breast Milk Alcohol Test Strips, the federal health agency said Friday.

"UMI has notified the FDA that it has stopped all operations and is no longer providing support for its tests," the FDA said in a statement. "The FDA is not able to confirm the performance of UMI's tests, raising concerns that the tests may not be safe and effective."

The tests may have been sold online by at least four distributors under the names AC&C, HealthyWiser, Home Health US and Prestige Biotech.

While UMI did recall undistributed tests, it did not do so for those already distributed or sold.

"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 agency said.

It's not clear why UMI issued the recall, but when UMI notified FDA about the recall of the tests and what about the performance can't be confirmed by the FDA.

Neither UMI nor the FDA immediately returned ABC News' request for comment.

In addition to not purchasing tests, the FDA is warning consumers to throw away all recalled tests; to test again for pregnancy, ovulation or UTIs with a different brand; and report any problems to the FDA's MedWatch program.

This is not the first time the FDA has issued an alert about recalled urine strip tests. Last year, the agency shared that Family Dollar was recalling several products that were stored "outside of labeled temperature requirements" including several pregnancy tests.


Monday, August 14, 2023 at 1:30PM by Mary Kekatos, ABC News Permalink