FDA FINALLY recalls nearly 330,000 pregnancy tests made by black market Chinese bio-company due to fears they’re contaminated or don’t work – WEEKS after DailyMail.com exposed the scale of the problem

The Food and Drug Association (FDA) has finally recalled hundreds of thousands of pregnancy tests made by a suspicious Chinese-linked bio-company.

Officials said Americans who own one of more than a dozen tests made by Universal Meditech Inc should ‘immediately stop using and destroy’ the kits. The same company was subject to a separate 2022 recall of illegal Covid tests made using millions in government funding. 

DailyMail.com has been reporting for weeks about how diagnostic tests made by the company posed a risk to public health, based on warnings from several health experts.

There are concerns that the tests could give inaccurate results or be contaminated. One of the distributors of the tests was recently found to be operating out of an illegal lab in California that officials there described as ‘filthy’ and ‘putrid’. 

The black market biolab was busted earlier this year when government officials found hundreds of vials containing diseases such as Covid and malaria, nearly a thousand dead and dying mice, and biomaterials like blood and plasma stored haphazardly in faulty freezers.   

The Universal Meditech Inc recall included pregnancy tests as well as urinalysis and ovulation test strips. The recall applies to nearly 330,000 tests distributed nationwide. It remains unclear how many people purchased and used the tests, which run the risk of being dangerous as well as inaccurate

Local and federal officials raided an unassuming warehouse in Reedley – home to just over 25,000 residents – where they discovered a lab of horrors with suspicious links to China. Some of the hundreds of thousands of pregnancy and ovulation tests recalled by the FDA were distributed by the company that oversaw the black market biolab 

Independent experts told DailyMail.com weeks ago that the tests – manufactured by Universal Meditech and distributed by a smattering of companies including Prestige Biotech – posed a health threat to the public but FDA was slow to act.

Now, the FDA is warning Americans to toss out the 329,567 pregnancy, ovulation, and urinalysis tests. There are a wide range of brands and test varieties included in the recall as well as several distributors. 

Prestige Biotech, though, was the subject of close scrutiny after officials in Reedley, California, a sleepy town near Fresno, discovered an illegal lab overseen by the company in which it was storing hundreds of vials of infectious agents ranging from Covid and malaria to HIV and the bacteria that cause meningitis and TB. 

The latest recall comes after another in December 2022, this time concerning tens of thousands of illegal Covid tests made by UMI before it was subsumed by Prestige.

Over a year before that recall, UMI had taken advantage of a federal handout program established during the height of the pandemic, the Paycheck Protection Program. 

Through that program, UMI received two forgivable loans totaling $150,000 in 2020 and 2021. 

In the lab of horrors run by Prestige, officials also discovered about 1,000 dead and dying lab mice, containers of blood and plasma haphazardly tossed in faulty freezers, and biohazardous waste disposed of unsafely.   

While it is unclear whether the tests were manufacturered at the Reedley lab, the FDA recall makes clear that Prestige had a hand in the tests getting out to consumers. 

Joe Prado, assistant director of the Fresno County Department of Public Health told DailyMail.com: ‘I am not aware of how many of those kits were manufactured in Fresno. We have thousands of test kits onsite we are still working through for destruction.’ 

And though UMI is the subject of the sweeping recall, the tests may not display that company as the manufacturer, but rather one of several other names such as DiagnosUS, HealthyWiser, and PrestiBio. 

This could make it more difficult for consumers to know for sure whether they tests they have in their possession are those that the FDA said need to be destroyed as soon as possible. 

Nearly 1,000 mistreated and malnourished white lab mice were discovered at the facility in subpar conditions. About 200 of them were already dead. The rest have been humanely euthanized by a veterinarian

Among hundreds of vials of infectious viruses and bacteria, many of which were stored improperly in shoddy freezers, were samples of malaria, shown here, alongside Chinese characters. Other infectious agents found included strains of the herpes virus, the bacterium that causes meningitis,  chlamydia, Covid-19, and HIV

Investigators also found containers of plasma and blood of unknown origin and for unknown purposes

The FDA confirmed the number of tests that were made available to the public, but was not able to confirm how many were sold and consequently used.  

UMI had been operating legally prior to its closure in late 2022, with its facility in the city of Fresno properly licensed and permitted from the state to produce pregnancy, ovulation, and menopause diagnostic tests. 

In December 2022, the FDA, which must issue pre-market approval for diagnostic tests, recalled approximately 56,000 of UMI’s Covid tests in California and Texas, citing the company’s lack of pre-market approval from the agency.

That recall did not mention the pregnancy tests.

Prestige took over all assets – including hundreds of haphazardly stored vials of disease-causing viruses and bacteria — and moved them to a warehouse in Reedley, California around December 2022.

Shortly after that in late 2022, the black-market lab was brought to the attention of officials when a code enforcement officer noticed a garden hose sticking out of a building where it shouldn’t have been.

The origins of Prestige Biotech, which had jurisdiction over the hundreds of chemicals, viruses, and biological materials, as well as the mistreated animals and faulty equipment, are still being unraveled, but its owners reported to county officials that they lived in China.

Prestige Biotech is still under investigation by local officials and it is unclear whether and to what extent officials representing the new, Chinese-linked company were also part of UMI. 

The recall covers the following tests: One Step Pregnancy Test, DiagnosUS One Step Ovulation Test, To Life hCG Pregnancy Urine Test, Am I Pregnant Pregnancy Midstream Test, DeTec hCG Pregnancy Urine Test, as well as four from the brand HealthyWiser and six from PrestiBio.