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The Food and Drug Administration has recalled at least 15 at-home tests manufactured by Fresno, CA-based Universal Meditech Inc. (UMI), citing their potential ineffectiveness.
A reported 330,000 tests — which are used for pregnancy, ovulation, and urinary tract infections — were distributed and sold online by at least four distributors, according to FDA officials. Those distributors are AC&C Distribution LLC, HealthyWiser, Home Health US Inc., and Prestige Biotech Inc. They might have been distributed by other distributors, too.
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Among the tests that the FDA is "warning consumers and patients to not use" are One Step Pregnancy Test, DiagnosUS One Step Ovulation Test and HealthyWiser UriTest UTI Test Strips. The full list of tests can be found here.
"UMI has notified the FDA that it has stopped all operations and is no longer providing support for its tests. 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 FDA said in a statement. "While UMI initiated a recall to remove undistributed tests from their distributors, UMI did not initiate a recall for tests that were already distributed to consumers. 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."
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The FDA urges people to not purchase the UMI tests; those that have are asked to immediately stop using them and destroy the tests by throwing them away.
"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 agency suggests. "Any adverse events or quality problems experienced with the use of these tests [should be reported] to the FDA's MedWatch Adverse Event Reporting program."
The UK's Daily Mail reports that "in December 2022, the FDA, which must issue pre-market approval for diagnostic tests, recalled approximately 56,000 of UMI's COVID tests in California and Texas, citing the company's lack of pre-market approval from the agency."
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