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Do not use: FDA recalls some tests for pregnancy, ovulation and urinary tract infections
View Date:2025-01-11 13:56:02
The Food and Drug Administration has issued a recall for a set of pregnancy, ovulation, and urinary-tract-infection tests because the agency said it can no longer guarantee they are safe or effective.
People should not use the following tests manufactured by Universal Meditech, Inc.
- 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
Product recalls: Check USA TODAY's database for latest recall news
Universal Meditech has notified the FDA that it has stopped all operations and is no longer providing support for its tests, according to the recall issued on Friday.
The FDA said it could not confirm the performance of the company's tests, raising concerns they may not be safe or effective.
Latest car recalls:Toyota, Chrysler among nearly 270,000 vehicles recalled last week
Where were the tests sold?
The FDA said the tests have been sold to consumers by at least four distributors:
- AC&C Distribution, LLC.
- HealthyWiser
- Home Health US Inc.
- Prestige Biotech Inc.
What do I do if my test is part of the recall?
Consumers should immediately stop using the recalled products and throw them out.
Those with questions can email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.
Natalie Neysa Alund covers breaking and trending news for USA TODAY. Reach her at nalund@usatoday.com and follow her on X, the platform formerly known as Twitter @nataliealund.
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