FDA issues warning for pregnancy tests tied to illegal Reedley lab

REEDLEY, Calif. (KFSN) -- Thousands of medical tests tied to an illegal Reedley lab are now part of a new warning from the FDA.

The products were manufactured by Universal Meditech, Incorporated.
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They include pregnancy and ovulation tests - plus strips to test for alcohol in breast milk.

The FDA says since the company stopped operations, there are concerns the tests may not be safe and effective.

Dr. Amy Autry with UCSF Fresno says having accurate pregnancy tests is important for expecting mothers.

"I have to say this is a horrible situation. But in general, I think being able to have patients feel empowered to find out about their own health conditions in over-the-counter medical tests is just a great advance in medical care," explained Dr. Autry.



Over 15 different tests manufactured by Universal Meditech, Inc. were sold online at AC&C Distribution, HealthyWiser, Home Health US, and Prestige Biotech.
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They include:

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

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The Reedley facility was first discovered last year.

Officials say a simple code violation led to the discovery of an operation that was unlicensed and unpermitted.

In March of this year- the Fresno County Department of Public Health and the City of Reedley obtained a court-issued warrant to inspect the property.

Health officials found refrigerators filled with chemicals, human blood, about 1,000 mice - plus illegal Covid and pregnancy tests.



Now, the FDA is advising against the use of these tests.

Dr. Autry says if you took a test and it was positive, it is best to re-confirm with a reliable company.

"And if it was negative, and you were reassured, and a positive test would change your life decision, you should take a test and consult medical care, based on the results," said Dr. Autry.

A full list and the FDA warning can be found here.

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