By Eva Fu
June 2, 2022 Updated: June 3, 2022
Early
in the COVID-19 pandemic, when front-line medical
workers in the United States were desperate to acquire crucial medical gear and
supplies, a Texas-based mobile health company paid about $500,000 for 100,000
antibody test kits from China—the only place at the time that was selling
the much-needed products.
But the
kits, which were supposed to fill orders from the U.S. military and state
customers, never went further than the warehouse where the products were
delivered before July 2020.
Following
months of delays after a concerning number of the tests were determined to be
defective, the Texas-based company, AnyPlace MD, has sued the China-based seller in the
Austin division of the U.S. District Court for the Western District of Texas in
hopes of recouping its losses.
The
contract agreed to in May 2020 required Shane Stevens, CEO and owner of
AnyPlace MD, to make a 75 percent down payment totaling $481,125 to Anhui
DeepBlue Medical Technology, the Chinese test kit supplier, with the remaining
$118,875 due a month later. After receiving the tests, Stevens said he quickly
discovered, upon running a sample check, that a significant number of the kits
produced false-positive results or “ghost lines”—lines that are hard to
interpret and “appear to indicate a positive test.”
An
early July 2020 email exchange with a joint venture partner, Reliant Immune
Diagnostics, a second plaintiff in the lawsuit,
highlighted a screenshot taken from the U.S. Food and Drug Administration’s
website showing that DeepBlue, along with four other China-based COVID-19 test
manufacturers, was flagged by the U.S. regulator as having products that
“should not be distributed.”
AnyPlace
apparently isn’t the only company that has filed complaints about the
China-based supplier. In Laredo, Texas, investigators from the U.S. Department
of Homeland Security seized 20,000 DeepBlue test kits, after health department
officials determined that the tests had only a 20 percent accuracy rate,
according to local media reports from April 2020.
Around
that time, defective medical supplies from China, such as masks and testing
kits, were already drawing backlash from countries such
as Finland, the UK, and Ireland, leading to recalls of millions of items. In
August 2020, Sweden announced that 3,700 residents were erroneously told they had the virus
due to defective testing kits made in China.
On July
10, 2020, AnyPlace and Reliant Immune Diagnostics contacted Rallo
Holdings, the company that had brokered the deal with DeepBlue, rejecting the
goods and asking for a refund. Stevens would spend the next few months trying
to get the nearly $500,000 back.
When he
was eventually connected with Li Zeyu, a DeepBlue representative, in September
2020, Li apologized for the delay in refund, saying that the company was
working on securing sales for the products in Mexico or other South American countries,
so that there “will be not lost or just a small lost [sic].”
“Why
are you guys trying to sell these tests to anyone else?” Stevens replied,
according to a message history he shared with The Epoch Times. “They are not
good. Ghost [lines], false positives … They are not good tests.”
Li
responded that AnyPlace’s allegations about the lab results “were not correct,”
and said that the company had only agreed to the refund because of the FDA’s
delisting.
“By the
way. deep blue sold about 10 million test kits total. we got bad result and
refund less than 50k total. … So we don’t think there is a big problem in our
products,” Li told Stevens on the Chinese messaging platform WeChat.
Anhui
DeepBlue Medical Technology officials didn’t respond by press time to a request
by The Epoch Times for comment.
The
FDA, while not specifically commenting on the imported products from Anhui
DeepBlue, told The Epoch Times in an email that it “intends to remove tests for
which FDA has either issued an EUA or has notified the test developer by email
that FDA declines to review, declines to issue, or otherwise decides not to
authorize the test for any reason.”
In an
April 2020 notice, the agency had warned that some test developers at the
time were “falsely claiming that their serological tests are FDA approved or
authorized, or falsely claiming that they can diagnose COVID-19.”
“The
FDA will take appropriate action against firms making false claims or marketing
tests that are not accurate and reliable,” it said.
According
to the lawsuit, the two U.S. firms said that they mistakenly believed that
an FDA certificate document shared by DeepBlue, which was issued to mark
an antibody test registration with the FDA, would ultimately lead to the
product receiving FDA approval.
The
upfront payment that AnyPlace made represented 50 percent of the company’s cash
reserves.
“It
hurt us badly,” Stevens told The Epoch Times. “We had to stop buying COVID
tests in the volumes that we were doing for quite some time while we recovered
and recouped.”
The lawsuit was his “last resort,” he said, and he
remains “very hopeful” for its success.
“If you
ask other folks who have tried to deal with companies in China, they might say
that it’s a low probability. But a lot of times, I just have to do what I think
is right. And in the back of my head, I’m thinking, what if some other company
doesn’t have the resources? What if some other companies put everything on the
line to try and buy something from them? That would have bankrupted that
company,” he said.
“It’s
dangerous having companies out there that are like this. … So I feel it’s an
obligation for me to do it, regardless of the outcome.”
https://www.theepochtimes.com/lawsuit-seeks-damages-over-100000-covid-19-tests-imported-from-china_4506827.html
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