REEDLEY – On Aug. 28, embattled pregnancy and COVID test manufacturer Universal Meditech, Inc. (UMI) announced the company is going out of business as it continues its nationwide recall of all products manufactured between March 2021 and November 2022.
UMI has been in the national crosshairs since the Mid Valley Times reported the company was illegally storing thousands of chemicals and other products, including laboratory mice, in an abandoned warehouse in Reedley.
The latest company announcement, which was published Aug. 31 on the U.S. Food and Drug Administration (FDA) website, said the reason for the product recall was because the company was going out of business and would not be able to continue fulfilling any post-market responsibilities for its products. The announcement of the initial recall was announced on July 1.
According to the announcement, 16 products are being recalled. UMI said consumers should either throw away the products or return them to UMI at the company’s expense. UMI initially distributed the products to distributors in California, New York, New Jersey and Florida. These distributors sold the products nationwide.
After first reported in the Times, UMI and its successor company, Prestige Biotech, Inc. (PBI), gained national attention after Reedley city officials discovered PBI had illegally stored over half a million COVID and pregnancy tests along with thousands of chemicals – many of which were stored in unmarked vials. There were also infectious agents, including herpes, rubella, and e-coli, as well as nearly 1,000 laboratory mice – many of which were dead on the premises with the remainder having to be euthanized.
The discovery gained national headlines and resulted in calls for stricter regulations and greater oversight for privately-funded labs.
Reedley marked the end of UMI’s nomadic existence, which began in Canada and had stops in Tulare and Fresno. The Chinese-owned company is currently under investigation by the state of California as well as by multiple federal agencies.
The following products have been recalled:
- One Step Pregnancy Test
- 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 Test Strips
- hCG Pregnancy Cassette
- Am I Pregnant Midstream Test
- hCG Pregnancy Strips
- PrestiBio Breastmilk Alcohol Test Strip
- PrestiBio Ovulation and Pregnancy Strips
- PrestiBio Pregnancy Strips
- PresiBio Rapid Detection Pregnancy Test Midstream
- PrestiBio Ketone Test Strips
- PrestiBio Urinalysis Test Strip