FDA warns against using certain pregnancy, ovulation, UTI tests

Apr 27, 2024

August 14, 2023 / 10:18 AM / CNN

(CNN) -- Consumers shouldn't use certain tests manufactured by Universal Meditech Inc., the US Food and Drug Administration warned Friday, including those that test for pregnancy, ovulation and urinary tract infections.

"UMI has notified the FDA that it has stopped all operations and is no longer providing support for its tests," the agency said. "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 California-based company has recalled undistributed tests but not those that have already been distributed to consumers.

Consumers are advised not to purchase or use the following Universal Meditech tests but rather to throw them away:

The tests may have been distributed under brand names such as AC&C, HealthyWiser, Home Health US and Prestige Biotech.

Anyone who has used one of these tests and still wants results should test again with a different brand and reach out to a health care provider if they have concerns about accuracy.

Consumers may report problems with devices or tests to the FDA through its MedWatch program.

First published on August 14, 2023 / 10:18 AM

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