The Food and Drug Administration is issuing a warning to consumers regarding at-home tests made by Universal Meditech, Inc. (UMI). UMI was operating an illegal medical lab in Reedley, California, which was recently shut down by local, state, and federal agencies. The authorities are currently working to clear the site, dispose of hazardous materials, 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 on Friday. “The FDA is unable to confirm the performance of UMI’s tests, raising concerns about their safety and effectiveness.”
UMI produced various strip-based tests, primarily pregnancy tests, but also tests for ovulation, ketones, and alcohol in breast milk. These tests were sold under different names, including DiagnosUS, HealthyWiser, DeTec, and PrestiBio. They were available for purchase online from at least four distributors, who may not have disclosed UMI as the manufacturer. The known distributors are AC&C Distribution, LLC; HealthyWiser; Home Health US Inc.; and Prestige Biotech Inc. The FDA warns that there may be other distributors that are unknown.
UMI also manufactured COVID-19 tests under the name Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits, which were recalled in January. The recall was initiated after the FDA discovered that UMI was selling the tests without proper clearance or approval.
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The FDA advises consumers not to purchase any UMI tests, to discontinue use if they have already bought them, and to retest using a different test if they have already used UMI tests.
Earlier this year, multiple agencies collaborated to uncover UMI’s unlicensed laboratory in Reedley, located in Fresno County. The lab was found to be in deplorable conditions, filled with lab equipment, refrigerators, freezers, incubators, and other machinery. It also housed nearly 1,000 laboratory mice, which were allegedly subjected to inhumane treatment. While some mice were found dead, the remaining animals were euthanized. Authorities also discovered numerous unidentified chemicals and vials of biohazardous materials, including blood and urine. Testing conducted by the Centers for Disease Control and Prevention identified at least 20 infectious agents, including SARS-CoV-2, HIV, and a herpes virus.
Hosed
The existence of the lab in Reedley was initially brought to the attention of local officials when a code enforcement officer noticed an illegally attached garden hose at the back of the warehouse, which was only supposed to be used for storage. According to a detailed timeline presented by Joe Prado, the assistant director of the health department, the discovery was made in December 2022.
Following the discovery, local authorities faced difficulties obtaining information about the lab and its responsible parties. Based on the information gathered thus far, it appears that UMI had previously operated a licensed but problematic lab in Fresno from 2018 to 2022. After being evicted from the Fresno location, UMI secretly relocated to the unlicensed facility in Reedley between November and December 2022, where the company continued its operations illegally.
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In Reedley, the warehouse tenant was listed as Prestige Biotech, which is believed to be financially linked to UMI. However, local authorities suspect that consultants and representatives associated with UMI and Prestige deliberately withheld information and obscured the lab’s activities. Prestige president Xiuqin Yao and UMI’s president, Xiao Xiao Wang, were uncooperative. Ars reached out to UMI for comment but did not receive an immediate response.
In a presentation to the board of supervisors, Prado stated that representatives from Prestige visited the health department in March but provided no useful information, only evasive responses. The lack of transparency from the companies has fueled conspiracy theories and anti-Chinese sentiment.
Reedley City Manager Nicole Zieba, speaking after Prado’s presentation, suggested that UMI and Prestige’s troubled history extended beyond their eviction from Fresno at the end of 2022.
“This was a company with a history of misconduct. They were kicked out of Canada, then went to Texas and got kicked out again. They came to California, went to Fresno, got kicked out, went to Tulare, got kicked out, returned to Fresno, got kicked out again, and finally ended up in Reedley,” Zieba said. She commended the city’s efforts in investigating the lab, which ultimately led to its closure, stating, “This little David city took down Goliath with a green garden hose.”
Federal agencies, including the FBI, CDC, FDA, and the Environmental Protection Agency, are still investigating the case and collaborating with local officials. Zieba mentioned that the city is still in the process of cleaning out the warehouse and has come across additional biological materials. City workers have discovered “jars of urine and peed on pregnancy tests” while clearing out desks and preserving documents.
“My hope is that by the time we enter the fall season, this warehouse in Reedley will be empty, just like we thought it was for the past decade,” Zieba concluded.
The Food and Drug Administration (FDA) has issued a safety alert in response to a massive bust of an illegal laboratory distributing unapproved pregnancy tests to consumers. The FDA has put health care professionals and patients on notice that these pregnant tests can be potentially dangerous due to their lack of regulation and testing.
The illegal laboratory was operating in Washington, D.C. and was selling pregnancy tests without the required FDA review and approval process. The tests could not meet the standards set forth by the FDA and hence posed a significant risk to patients. The tests lacked the necessary quality control processes and may not have been correctly calibrated. As such, the results could easily be inaccurate and unreliable.
The FDA has urged health care professionals and patients to use only FDA-approved pregnancy tests. The agency has stressed that the use of unapproved pregnancy tests can have serious health implications, especially for pregnant women. The FDA noted that accurate results from an accurate and reliable test are essential for timely care and management of a pregnancy.
The FDA has advised consumers to check that any pregnancy test they are considering buying is FDA-approved. Health care providers should be sure to properly ascertain the status of the test they are using and to purchase only FDA-approved tests.
The FDA has also encouraged individuals to report any suspicious activity related to the sale of unapproved medical devices, especially those related to pregnancy testing. This will help the FDA ensure that only FDA-approved tests are used, safeguarding patients from potentially dangerous and inaccurate results.
The FDA will continue to monitor the sale of pregnancy tests and take appropriate action if illegal activity is found. The agency has promised to keep health care professionals and consumers informed on upcoming issues as well as progress made in protecting consumers from unapproved and potentially dangerous tests.
