Please ensure Javascript is enabled for purposes of website accessibility
FDA Recalled COVID-19 Tests From Fresno Lab Linked to Illegal Reedley Facility
By admin
Published 10 months ago on
August 1, 2023

Share

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.

Universal Meditech’s Former Fresno Location

RELATED TOPICS:

DON'T MISS

Paul McCartney Becomes Britain’s First Billionaire Musician

DON'T MISS

California Cracked Down After a Crash Killed 13 Farmworkers. Why Are Workers Still Dying on the Road?

DON'T MISS

These Rare Chainsaws Are Worth Big Bucks to Collectors

DON'T MISS

Jewish Lobby Presses California Lawmakers to Combat Antisemitism

DON'T MISS

Opinion: How Urban Renewal Ruined Everything

DON'T MISS

California Wine Squeezed Dry: Insiders Say It’s Time to Pull up Acreage

DON'T MISS

Alabama Mercedes Employees Overwhelmingly Vote Against Joining Union, Slowing UAW Effort in South

DON'T MISS

Stock Market Today: Dow Finishes Above 40,000 to Cap Wall Street’s Latest Winning Week

DON'T MISS

Where Do State Lawmakers Stand on War in Gaza, Campus Protests?

DON'T MISS

High-Speed Rail Now Working to Extend Valley Line to 171 Miles

UP NEXT

California Cracked Down After a Crash Killed 13 Farmworkers. Why Are Workers Still Dying on the Road?

UP NEXT

These Rare Chainsaws Are Worth Big Bucks to Collectors

UP NEXT

Jewish Lobby Presses California Lawmakers to Combat Antisemitism

UP NEXT

Opinion: How Urban Renewal Ruined Everything

UP NEXT

California Wine Squeezed Dry: Insiders Say It’s Time to Pull up Acreage

UP NEXT

Alabama Mercedes Employees Overwhelmingly Vote Against Joining Union, Slowing UAW Effort in South

UP NEXT

Stock Market Today: Dow Finishes Above 40,000 to Cap Wall Street’s Latest Winning Week

UP NEXT

Where Do State Lawmakers Stand on War in Gaza, Campus Protests?

UP NEXT

High-Speed Rail Now Working to Extend Valley Line to 171 Miles

UP NEXT

Beautify Fresno Combines Dog Adoption, Litter Removal in Unique Saturday Event

Jewish Lobby Presses California Lawmakers to Combat Antisemitism

2 days ago

Opinion: How Urban Renewal Ruined Everything

2 days ago

California Wine Squeezed Dry: Insiders Say It’s Time to Pull up Acreage

2 days ago

Alabama Mercedes Employees Overwhelmingly Vote Against Joining Union, Slowing UAW Effort in South

3 days ago

Stock Market Today: Dow Finishes Above 40,000 to Cap Wall Street’s Latest Winning Week

3 days ago

Where Do State Lawmakers Stand on War in Gaza, Campus Protests?

3 days ago

High-Speed Rail Now Working to Extend Valley Line to 171 Miles

3 days ago

Beautify Fresno Combines Dog Adoption, Litter Removal in Unique Saturday Event

3 days ago

Bulldogs’ Gilmore Named MW Softball Pitcher of the Year

3 days ago

The Latest | Dozens of Israeli Protesters Attack a Truck in an Apparent Effort to Block Gaza Aid

3 days ago

Paul McCartney Becomes Britain’s First Billionaire Musician

LONDON — Paul McCartney is a billionaire Beatle. According to figures released Friday, the former member of the Fab Four is the first Britis...

2 days ago

2 days ago

Paul McCartney Becomes Britain’s First Billionaire Musician

2 days ago

California Cracked Down After a Crash Killed 13 Farmworkers. Why Are Workers Still Dying on the Road?

2 days ago

These Rare Chainsaws Are Worth Big Bucks to Collectors

2 days ago

Jewish Lobby Presses California Lawmakers to Combat Antisemitism

2 days ago

Opinion: How Urban Renewal Ruined Everything

2 days ago

California Wine Squeezed Dry: Insiders Say It’s Time to Pull up Acreage

3 days ago

Alabama Mercedes Employees Overwhelmingly Vote Against Joining Union, Slowing UAW Effort in South

3 days ago

Stock Market Today: Dow Finishes Above 40,000 to Cap Wall Street’s Latest Winning Week

MENU

CONNECT WITH US

Search

Send this to a friend