FDA urges public to throw away pregnancy, UTI tests from unauthorized California lab

The FDA is urging the public to throw away any pregnancy or ovulation tests manufactured by Universal Meditech, Inc.—a final step to remove the troubled company’s products from the market following previous diagnostic recalls and the shutdown of its California production facilities after they were found to be operating without permits.

Per the FDA’s notice, its reviewers have been unable to confirm whether the company’s tests are safe, effective or accurate. Meanwhile, Universal Meditech’s locations in the greater Fresno area have seen lab equipment and biological materials seized and destroyed by county health inspectors, according to reports from the local ABC affiliate station KFSN-TV.

The federal agency said Universal Meditech has stopped all commercial operations. However, its tests have also been sold online directly to consumers, potentially under the brand names of four different distributors: Prestige Biotech, HealthyWiser, Home Health US and AC&C Distribution.

They include home pregnancy and ovulation tests, as well as test strips to help diagnose urinary tract infections and detect the presence of alcohol in expressed breast milk. 

“Immediately stop using and destroy these recalled tests by placing them in the trash,” the FDA said in its notice. “While UMI initiated a recall to remove undistributed tests from their distributors, UMI did not initiate a recall for tests that were already distributed to consumers.”

The company previously recalled its COVID-19 antigen tests in January, including 56,300 Skippack Medical Lab kits that were shipped without clearance from the FDA. The same test had been the focus of a recall launched by SML Distribution in early 2022 for the same reason, spanning more than 209,000 units.

According to KFSN-TV, local officials found “unauthorized biological agents, samples of bodily fluid, infectious diseases, COVID and pregnancy tests and nearly 1,000 mice” at the lab facility in Reedley, California. 

In addition, a report from the Fresno Bee said that the location’s refrigerators included “coronavirus and other exotic contagions, such as malaria, Hepatitis B and C, chlamydia, human herpes and rubella, among others, used in the production of various test kits.”

The company also previously operated a warehouse laboratory in southwest Fresno, which caught fire in August 2020. An inspection afterward found Universal Meditech did not have a hazmat business plan and was storing ethanol on site.