Recall on Medical Test Kits After Illegal Chinese-Owned Manufacturing Plant in California Found with Biohazards
In December 2022, a code enforcement officer for the city of Reedley, California, discovered an illegal lab, Universal Meditech Inc., which was operating without a state license or other required permits.
The lab was manufacturing a wide variety of test kits, including pregnancy tests, ovulation tests, COVID-19 test kits, and various drug tests. Despite the test kits being sold as sterile, they were manufactured in unsanitary conditions.
The lab was also found to be improperly storing at least 20 infectious agents, including E. coli, coronavirus, malaria, hepatitis B and C, dengue, chlamydia, herpes, rubella, and HIV.
Multiple news sites report that Jesalyn Harper, the code enforcement officer, responded to an anonymous tip of cars parked outside an old, abandoned warehouse. What began as a routine code enforcement check turned surreal when officer Harper encountered rows of refrigerators hooked up to makeshift wiring, each containing blood samples, viruses, or bacteria. She also found approximately 1,000 white lab mice kept in overcrowded and contaminated conditions.
Harper learned that the company, Prestige Biotech, Inc., manufactured various medical test kits and that the company’s owner lived in China. Using broken English, three Asian women wearing lab coats, plastic gloves and surgical masks provided Harper with the owner’s phone number and email address.
Harper contacted a number of health agencies, but strangely, law enforcement and local authorities were told not to discuss the matter with the public.
Violations Overlooked by Authorities
Local, state, and federal authorities all launched investigations, but three months later they concluded that no criminal activity was occurring in the lab. The health agencies also stated the evidence showed that the lab did not pose a threat to public health or national security.
The mice, said to have been genetically engineered to carry SARS-CoV-2, were inspected by a veterinarian associated with the Lawrence Berkeley National Laboratory.
In March, 2023, after the investigations were complete, Reedley officials took legal action to shut down the lab, and as of July 7, 2023, all biological agents had been cleaned out and destroyed by the Fresno health department.
The FDA issued a warning about several of the test kits produced in the lab, and Universal Meditech issued a recall of tests that had already been sent to distributors, but not for tests that have already reached consumers.
Consumers Beware
Tests manufactured by Universal Meditech at the Reedley warehouse were sold online under the brand names of several distributors, including Prestige Biotech Inc., AC&C Distribution LLC, HealthyWiser, and Home Health U.S. Inc. The FDA recommends consumers not purchase or use any of these tests, and that if anyone has used any of these tests, they should not trust the results and test again with a different test.
The specific tests affected by the FDA’s warning are:
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
PrestiBio Pregnancy Strips
PrestiBio Rapid Detection Pregnancy Test Midstream
PrestiBio Ovulation Strips
PrestiBio Urinalysis Test Strip 10 Parameters
PrestiBio Ketone Test Strips
PrestiBio Breast Milk Alcohol Test Strips
Here are the FDA’s recommendations regarding these tests:
Do not purchase or use any of these tests.
If you’ve purchased any of these tests, throw them out.
If you’ve used any of these tests, do not trust the results. Test again with a different test.
If you’ve experienced a quality problem with any of these tests, contact the FDA’s MedWatch Adverse Event Reporting program.
Questions Remain
Why were local law enforcement and city management given a gag order when potentially lethal pathogens were being handled haphazardly in unapproved and unmonitored conditions?
Why are Chinese-owned bio-hazard companies that are operating unregulated and without any licensure being given a get-out-of-jail-free card?
How many more unregulated and unlicensed Chinese-run Biolabs are operating in the United States under the radar, and what danger do they present for accidentally leaking a deadly pathogen?