The Food and Drug Association (FDA) has taken action and recalled a significant number of pregnancy tests produced by a dubious Chinese-affiliated bio-company. Officials have issued a warning advising American consumers who possess any of the over a dozen tests produced by Universal Meditech Inc to discontinue their use immediately and dispose of them. This particular company was also involved in a separate recall of illicit Covid tests that were manufactured using government funding in 2022. Several health experts had previously alerted DailyMail.com about the potential risks to public health posed by diagnostic tests from this company. These concerns included the possibility of inaccurate results or contamination. One of the distributors of these tests was recently found operating in an illegal laboratory in California, which was described as unsanitary and repulsive by local officials. This illicit biolab was discovered earlier this year, and it contained numerous vials of diseases such as Covid and malaria, along with nearly a thousand dead and dying mice, and improperly stored biomaterials like blood and plasma.
The recall by Universal Meditech Inc encompasses pregnancy tests, urinalysis test strips, and ovulation test strips. This recall covers approximately 330,000 tests distributed across the country. The exact number of people who purchased and used these tests is unknown, but it is essential to note that they pose potential dangers and may provide inaccurate results. A warehouse in Reedley, a small town with just over 25,000 residents, was raided by local and federal officials. This warehouse was found to have connections to the black market biolab and had distributed a portion of the hundreds of thousands of pregnancy and ovulation tests that were subsequently recalled by the FDA. Even though experts had already warned DailyMail.com about the public health risks of tests manufactured by Universal Meditech and distributed by various companies, including Prestige Biotech, the FDA was slow to respond. Now, the FDA is urging the public to discard 329,567 pregnancy, ovulation, and urinalysis tests. The recall encompasses multiple brands and varieties of tests, as well as several different distributors. Prestige Biotech faced intense scrutiny after authorities in Reedley, California uncovered an illegal lab that stored hundreds of vials of infectious agents, including Covid, malaria, HIV, and bacteria responsible for meningitis and tuberculosis.
This recent recall follows another one in December 2022 for illegal Covid tests produced by Universal Meditech Inc before it was acquired by Prestige. Over a year before that recall, Universal Meditech Inc had received $150,000 in forgivable loans through the Paycheck Protection Program established during the peak of the pandemic. In the Prestige-run lab discovered by officials, approximately 1,000 malnourished and mistreated white lab mice were found in unsatisfactory conditions, with about 200 already deceased. These remaining mice were humanely euthanized by a veterinarian. Among the countless vials of infectious viruses and bacteria, stored haphazardly in faulty freezers, were samples of malaria, with Chinese characters accompanying them. Additionally, containers filled with plasma and blood of unknown origin and purpose were found. The FDA has confirmed the number of tests available to the public but has been unable to determine the quantity sold and used.
The recalled tests were manufactured by Universal Meditech and 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, and several from the brand PrestiBio. It is important to note that these tests may not display Universal Meditech as the manufacturer but may bear names such as DiagnosUS, HealthyWiser, and PrestiBio, making it difficult for consumers to identify which tests they possess that need to be discarded according to the FDA’s instructions.
While Universal Meditech Inc operated lawfully before its closure in late 2022, with its facility in Fresno possessing the necessary licenses and permits for the production of pregnancy, ovulation, and menopause diagnostic tests, the FDA recalled approximately 56,000 of the company’s Covid tests in California and Texas in December 2022 due to a lack of pre-market approval from the agency. This recall did not mention the pregnancy tests. After that, Prestige took control of all assets, including poorly stored vials containing disease-causing viruses and bacteria, and relocated them to a warehouse in Reedley, California. It was during this time, in late 2022, that authorities became aware of the existence of the black-market lab when a code enforcement officer noticed an anomalous garden hose protruding from an inappropriate location. The origins of Prestige Biotech, responsible for the abundant chemical substances, viruses, biological materials, mistreated animals, and faulty equipment, are still being unraveled. However, the owners claimed to be residing in China when reporting to county officials. The investigation into Prestige Biotech is ongoing, and it remains unclear to what extent the representatives of this new, Chinese-affiliated company were involved with Universal Meditech Inc.
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