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August 14, 2023

FDA warns against using certain pregnancy, ovulation and UTI tests

People are advised to throw away any products manufactured by Universal Meditech because the federal agency says it cannot confirm whether they are safe and effective

Women's Health Pregnancy
FDA Pregnancy Tests cottonbro studio/pixels

The U.S. Food & Drug Administration warns consumers not to use pregnancy, UTI and ovulation tests manufactured by Universal Meditech Inc. because it can no longer ensure their safety and effectiveness. The photo above is a stock image of a pregnancy test.

People should not to use any health tests manufactured by Universal Meditech Inc. because the company has ceased operations and is no longer providing support for any of its tests, the U.S. Food and Drug Administration advised. 

The FDA said it is unable to confirm whether any of the company's testing products are safe and effective. Universal Meditech's products include tests for pregnancy, ovulation and urinary tract infections. 

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The full list is shown below:

• 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
• To Life hCG Pregnancy Urine Test
• 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
• PrestiBio Breast Milk Alcohol Test Strips

The FDA said these tests have been sold to consumers online by at least four distributors – AC&C Distribution, Inc., HealthyWiser, Home Health US Inc. and Prestige Biotech Inc. The tests were sold under the brand names of these distributors, and also may have been sold by other distributors.

Although Universal Meditech, Inc. issued a recall for products held by these distributers, the company did not issue a recall for products that were sold to consumers.

Consumers are advised not to purchase any of these products and to throw them away if they already bought them. Anyone who used these tests and received results is advised to retake the test using a different product. Any adverse events or quality problems with these products should be reported to the FDA.

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