FDA problems security alert on pregnancy tests after bust on prohibited medical lab

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A picture of containers taken from the illegal UMI lab in Reedley, California.

 A picture of containers drawn from the illegal UMI lab in Reedley, California. The Food and Drug Administration is cautioning customers not to utilize any at-home tests made by Universal Meditech, Inc. (UMI), the company behind an unlawful medical laboratory concealed in a warehouse in the little city of Reedley, California. The laboratory was shut down previously this year by regional, state, and federal firms, which are still working to clear the site, correctly deal with all its harmful contents, and investigate those responsible.

" UMI has actually informed the FDA that it has actually stopped all operations and is no longer providing support for its tests," the FDA said in a security interaction Friday. "The FDA is unable to confirm the efficiency of UMI's tests, raising concerns that the tests might not be effective and safe."

UMI manufactured a variety of strip-based tests, primarily pregnancy tests, however likewise evaluates for ovulation, ketones, and alcohol in breast milk. The tests were offered under several names-- consisting of DiagnosUS, HealthyWiser, DeTec, and PrestiBio. They were available online from at least 4 distributors, which may not have identified UMI as the maker. The known distributors are: AC&C Distribution, LLC; HealthyWiser; Home Health United States Inc.; and Prestige Biotech Inc. The FDA cautions that there may be other suppliers that it does not learn about.

UMI likewise made COVID-19 tests under the name Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits, which were remembered in January. Those were remembered after the FDA found UMI was selling the tests without premarket clearance or approval.

The FDA recommends customers not to purchase any UMI tests, not to utilize them if they have actually already bought them, and, if they have already used them, to check again with a different test.

Previously this year, over a lots companies teamed up to bust UMI's unlicensed laboratory in Reedley, which is in Fresno County. The squalid lab was found teeming with lab devices, refrigerators, freezers, incubators, and other equipment. It included nearly 1,000 laboratory mice, which were presumably kept in inhumane conditions. While some were dead upon discovery, the remaining animals have given that been euthanized. Authorities likewise discovered numerous unknown chemicals and vials of biohazardous products, consisting of blood and urine. Testing by the Centers for Disease Control and Prevention identified at least 20 transmittable agents, including SARS-CoV-2, HIV, and a herpes infection.


Authorities in Reedley were very first tipped off to the laboratory's existence after a regional code enforcement officer observed an illegally connected garden home in the back of the storage facility, which was supposed to be used just for storage. According to a comprehensive timeline, presented last week at a Fresno County Board of Supervisors Meeting by Joe Prado, the assistant director of the health department, that preliminary discovery was made in December 2022.

Following the discovery, regional officials had a hard time to get information about what was happening at the site and who was responsible. Based upon what authorities have because had the ability to piece together, it appears that UMI had formerly run a licensed but struggling lab in close-by Fresno between 2018 and 2022. UMI was forced out from the Fresno place and secretly transferred to the unlicensed center in Reedley between November and December 2022, where the business apparently kept doing its service unlawfully.

In Reedley, the storage facility renter was listed as Prestige Biotech, which is stated to be financially accountable for UMI. But local authorities suggested that experts and representatives for UMI and Prestige appeared to obfuscate and keep info about what was going on in the laboratory. Eminence president Xiuqin Yao was not upcoming, Prado stated, neither was UMI's president, Xiao Wang. UMI did not instantly react to an ask for remark from Ars.

In his discussion to the board of managers, Prado said representatives for Prestige came to the health department in March however offered no details, simply a great deal of "hemming and hawing," he said. "I believe this was just the nature of this organization agent, where they would attempt to show compliance at some level, but they do not provide you the real information." The dearth of information about the companies and their work has fueled conspiracy theories and anti-Chinese sentiment.

Reedley City Manager Nicole Zieba, who spoke after Prado's discussion, recommended UMI and Prestige's distressed past extended much even more than the expulsion from Fresno at the end of 2022.

"This was a bad player company, a bad star business that was kicked out of Canada, they went to Texas, they got kicked out of Texas, they pertained to California ... they went to Fresno, tossed out of Fresno, went to Tulare, kicked out of Tulare, returned to Fresno, tossed out of Fresno, came to Reedley," Zieba said. "This little David city took down Goliath with a green garden pipe," she added, applauding the town's job at examining the laboratory, eventually causing its death.

Federal agencies, including the FBI, CDC, FDA, and the Environmental Protection Agency, are still investigating the case and consulting with regional officials. Zieba stated the city is still working to clear out the storage facility and stumbling upon extra biological products. She explained city workers now attempting to clean out desks and maintain files, only to find and open drawers "containers of urine and peed on pregnancy tests."

"My hope is that by the time we get in greatly into fall, this will be another empty storage facility in Reedley, like we thought it was for the last years," Zieba stated.

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