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FDA warns against using tests by Universal Meditech | Image Credit: © MP Studio – © MP Studio – stock.adobe.com.
The FDA has warned consumers to avoid using tests manufactured by Universal Meditech, Inc. (UMI).
Tests which should be avoided include the 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, and To Life hCG Pregnancy Urine Test.
Other tests to avoid include the 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, and PrestiBio Breast Milk Alcohol Test Strips.
This announcement occurred after UMI told the FDA it will no longer provide support for its tests. Since the FDA cannot confirm the performance of UMI’s tests, their safety and efficacy cannot be determined.
Consumers have been able to purchase UMI tests through the following distributors: AC&C Distribution, LLC, HealthyWiser, Home Health US Inc, and Prestige Biotech Inc. Certain tests may not have listed UMI as the manufacturer, and other distributors may also have sold the tests to consumers.
UMI has begun a recall to pull tests from distributors, but not from consumers who have already purchased tests. This has led the FDA to provide recommendations to consumers and patients in an effort to protect public health. This includes not using or purchasing tests manufactured by UMI.
Along with immediately halting use of tests manufactured by UMI, consumers should also dispose of them by placing them in the trash. Patients who have used one of the recalled tests and wish to see the results should test again using a different test.
If patients still have concerns over the accuracy of their test results, they should discuss these concerns with their health care provider. Any adverse effects or quality problems from test use should be reported to the FDA’s MedWatch Adverse Event Reporting program.
Reference
Do not use tests manufactured by Universal Meditech, Inc.: FDA Safety Communication. US Food and Drug Administration. August 11, 2023. Accessed August 15, 2023. https://www.fda.gov/medical-devices/safety-communications/do-not-use-tests-manufactured-universal-meditech-inc-fda-safety-communication?utm_medium=email&utm_source=govdelivery
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