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FDA is warning consumers not to use certain pregnancy tests

The tests were manufactured by Universal Meditech, Inc., which notified the FDA that it has stopped all operations.
FDA is warning consumers not to use certain pregnancy tests
Posted at 1:48 PM, Aug 15, 2023
and last updated 2023-08-15 15:47:46-04

The Food and Drug Administration is asking consumers not to use certain pregnancy, ovulation and urinalysis tests. 

The tests were manufactured by Universal Meditech, Inc., which notified the FDA that it had stopped all operations and is no longer providing support for the 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. 

UMI initiated a recall to stop tests from going to distributors, but it did not recall items already distributed to consumers. That's what prompted an FDA Safety Communication, so customers would know to stop using the tests. 

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If you have any of the following products, the FDA says you should throw them out:

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 recommends that people see their medical provider to confirm results if they've recently used one of the tests. 

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