FDA Recalled COVID-19 Tests From Fresno Lab Linked to Illegal Reedley Facility

By admin

Published 2 years ago on

August 1, 2023

Getting your Trinity Audio player ready...

COVID-19 tests distributed by a licensed Fresno medical lab with links to an illegal lab in Reedley were recalled in 2022 by the Food and Drug Administration.

The FDA called the Class I recall “the most serious type of recall” as the devices may cause serious injuries or death.

In May 2022, the FDA recalled 56,300 COVID tests from Pennsylania-based SML Distribution LLC. In February of this year, the FDA added Universal Meditech Inc. to the recall.

Neither company provided the FDA with data showing the tests worked correctly, according to a news release from the FDA.

The FDA called the Class I recall for Skippack Medical Lab SARS-CoV-2 COVID-19 “the most serious type of recall” as the devices may cause serious injuries or death.

“Universal Meditech Inc. is recalling Skippack Medical Lab COVID-19 Direct Antigen Rapid Tests (Colloidal Gold) because these tests were distributed to U.S. customers without authorization, clearance or approval from the FDA,” the FDA stated.

Inadequate Testing Data Provided, Says FDA

“Neither Universal Meditech Inc. nor SML Distribution LLC, has provided the FDA with adequate data to show that the test’s performance is accurate. This means there is a risk of potential false negative, false positive, or misinterpretation of results.”

While the company never received complaints about injuries or deaths, the FDA said the product may cause serious adverse health consequences including death.

Landlord Sought Universal Meditech’s Eviction in Fresno

GV Wire has also learned that the landlord for Universal Meditech had sought eviction for the business located in North Pointe Business Park in south central Fresno.

A complaint filed by Proper Defense Law Corp. in February 2023 against Universal Meditech Inc. as well as a number of its officers and associated other businesses, accused company officials of “direct oral misrepresentations,” “speaking half-truths” and “concealing material facts,” according to the court complaint.

Attorney Justin Vecchiarelli with Proper Defense Law said he was retained by Universal Meditech in a dispute with the company’s North Pointe landlord. There was a fire at Universal Meditech’s lab there in August 2020.

“During the litigation, the attorney-client relationship substantially broke down which resulted in my firm no longer providing legal services to Universal Meditech Inc. back in 2022, ” Vecchiarelli said in an e-mail to GV Wire on Tuesday.

The lawsuit is ongoing. Vecchiarelli would not comment further.

Calls made to North Pointe Business Park property management company were not returned before the publication of this story.

Vecchiarelli’s lawsuit seeks $25,000 in damages.