FDA issues safety alert on pregnancy tests after bust on illegal medical lab

The Food and Drug Administration is warning consumers not to use any at-home tests made by Universal Meditech, Inc. (UMI), the company behind an illegal medical lab hidden in a warehouse in the small city of Reedley, California. The lab was shut down earlier this year by local, state, and federal agencies, which are still working to clear the site, properly dispose of all its hazardous contents, and investigate those responsible.

“UMI has notified the FDA that it has stopped all operations and is no longer providing support for its tests,” the FDA said in a safety communication Friday. “The FDA is not able to confirm the performance of UMI’s tests, raising concerns that the tests may not be safe and effective.”

UMI manufactured a variety of strip-based tests, mostly pregnancy tests, but also tests for ovulation, ketones, and alcohol in breast milk. The tests were sold under several names—including DiagnosUS, HealthyWiser, DeTec, and PrestiBio. They were available online from at least four distributors, which may not have identified UMI as the manufacturer. The known distributors are: AC&C Distribution, LLC; HealthyWiser; Home Health US Inc.; and Prestige Biotech Inc. The FDA cautions that there may be other distributors that it doesn’t know about.

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

The FDA advises consumers not to buy any UMI tests, not to use them if they have already bought them, and, if they have already used them, to test again with a different test.

Earlier this year, over a dozen agencies teamed up to bust UMI’s unlicensed laboratory in Reedley, which is in Fresno County. The squalid lab was found brimming with lab equipment, refrigerators, freezers, incubators, and other machinery. It contained nearly 1,000 laboratory mice, which were allegedly kept in inhumane conditions. While some were dead upon discovery, the remaining animals have since been euthanized. Authorities also found hundreds of unknown chemicals and vials of biohazardous materials, including blood and urine. Testing by the Centers for Disease Control and Prevention identified at least 20 infectious agents, including SARS-CoV-2, HIV, and a herpes virus.

Hosed

Authorities in Reedley were first tipped off to the lab’s existence after a local code enforcement officer noticed an illegally attached garden house in the back of the warehouse, which was supposed to be used only 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 initial discovery was made in December 2022.

Following the discovery, local officials struggled to get information about what was happening at the site and who was responsible. Based on what authorities have since been able to piece together, it appears that UMI had previously operated a licensed but troubled lab in nearby Fresno between 2018 and 2022. UMI was evicted from the Fresno location and secretly relocated to the unlicensed facility in Reedley between November and December 2022, where the company apparently kept doing its business illegally.

In Reedley, the warehouse tenant was listed as Prestige Biotech, which is said to be financially responsible for UMI. But local authorities suggested that consultants and representatives for UMI and Prestige appeared to withhold and obfuscate information about what was going on in the lab. Prestige president Xiuqin Yao was not forthcoming, Prado said, neither was UMI’s president, Xiao Xiao Wang. UMI did not immediately respond to a request for comment from Ars.

In his presentation to the board of supervisors, Prado said representatives for Prestige came to the health department in March but provided no information, just a lot of “hemming and hawing,” he said. “I think this was just the nature of this business representative, where they would try to show compliance at some level, but they don’t give you the real information.” The dearth of data about the companies and their work has fueled conspiracy theories and anti-Chinese sentiment.

Reedley City Manager Nicole Zieba, who spoke after Prado’s presentation, suggested UMI and Prestige’s troubled past stretched much further than the eviction from Fresno at the end of 2022.

“This was a bad player company, a bad actor company that was kicked out of Canada, they went to Texas, they got kicked out of Texas, they came to California … they went to Fresno, kicked out of Fresno, went to Tulare, kicked out of Tulare, went back to Fresno, kicked out of Fresno, came to Reedley,” Zieba said. “This little David city took down Goliath with a green garden hose,” she added, commending the town’s job at investigating the lab, ultimately leading to its demise.

Federal agencies, including the FBI, CDC, FDA, and the Environmental Protection Agency, are still investigating the case and consulting with local officials. Zieba said the city is still working to clean out the warehouse and stumbling upon additional biological materials. She described city workers now trying to clear out desks and preserve documents, only to open drawers and find “jars of urine and peed on pregnancy tests.”

“My hope is that by the time we enter heavily into fall, this will be another empty warehouse in Reedley, like we thought it was for the last decade,” Zieba said.

https://arstechnica.com/?p=1961109