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Certain Tests for Pregnancy, Ovulation, UTIs Should Not Be Used, FDA Warns

A variety of tests for pregnancy, ovulation, urine, and breast milk should not be used because of concerns over efficacy and safety

By Physician’s Briefing Staff HealthDay Reporter

MONDAY, Aug. 14, 2023 (HealthDay News) — The U.S. Food and Drug Administration has warned that consumers should not use certain pregnancy, ovulation, urine, urinary tract infection, 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.

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 they have concerns about the accuracy of the test results, the FDA said.

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