healthmedicinet

The Food and Drug Association (FDA) has finally recalled hundreds of thousands of pregnancy tests conducted by a suspicious Chinese organic company.

Officials said Americans who own any of the more than a dozen tests created by Universal Meditech Inc should “immediately discontinue use and destroy the kits.” The same company was subject to a separate 2022 recall of illegal Covid tests conducted with millions of government funding.

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

There is concern that the tests could give inaccurate results or could be contaminated. One of the distributors, Prestige Biotech, was recently found to be working out of an illegal laboratory in California that officials there described as “filthy” and “tainted.”

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

Local and federal officials raided a humble 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 have been 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 few companies, including Prestige Biotech — posed a health threat to the public, but the FDA was slow to act.

Now the FDA is warning Americans to throw away the 329,567 pregnancy, ovulation, and urinalysis tests. A wide variety of brands and test varieties are included in the recall, as are several distributors.

However, Prestige Biotech came under close scrutiny after officials in Reedley, California, a sleepy town near Fresno, discovered an illegal laboratory under the company’s supervision in which it stored hundreds of vials of infectious agents ranging from Covid and malaria to HIV. . and the bacteria that cause meningitis and tuberculosis.

The latest recall comes after another in December 2022, this time relating to tens of thousands of illegal Covid tests conducted by UMI before being acquired by Prestige.

More than a year prior to that recall, UMI had benefited from 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.

At Prestige’s horror lab, officials also discovered about 1,000 dead and dying lab mice, containers of blood and plasma thrown haphazardly into faulty freezers, and biohazard waste disposed of unsafely.

While it’s unclear if the tests were manufactured at the Reedley lab, the FDA’s recall makes it abundantly clear that Prestige had a hand in the tests reaching consumers.

Joe Prado, deputy director of the Fresno County Department of Public Health told DailyMail.com, “I don’t know how many of those kits were made in Fresno. We have thousands of test kits on site that we are still working to destroy.”

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

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

Nearly 1,000 abused and malnourished lab white mice were found in substandard conditions at the facility. About 200 of them were already dead. The rest were humanely euthanized by a veterinarian

Among the hundreds of vials of infectious viruses and bacteria, many of which had been improperly stored in shoddy freezers, were samples of malaria, pictured here, alongside Chinese characters. Other infectious agents found included strains of the herpes virus, the bacteria 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 available to the public, but could not confirm how many were sold and subsequently used.

UMI was operating legally before closing in late 2022, and its Fresno city facility was properly licensed and authorized by the state to perform pregnancy, ovulation and menopause diagnostic tests.

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

That memory didn’t 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.

Soon after, in late 2022, the black market lab was brought to the attention of officials when a code enforcer 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 abused animals and faulty equipment, are still being unraveled, but the owners reported to provincial officials that they lived in China.

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

The recall includes 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 HealthyWiser brand and six from PrestiBio.