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US Medical Company Sues Chinese Manufacturer for 100,000+ Defective COVID Antibody Tests With False Positives


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A U.S. medical company is suing Chinese manufacturer Anhui DeepBlue in an effort to recover nearly half a million dollars it lost buying defective antibody tests that showed false-positive results, according to American Military News.

AnyPlace MD — a nationwide mobile medical company that provides “point of care testing with real-time results” based in Austin, Texas — first sought a contract to purchase DeepBlue’s tests in March 2020.

Shane Stevens, CEO of AnyPlace MD revealed that upon inspection, they discovered that DeepBlue’s tests were “terrible.”

From American Military News:

Months later, Stevens was finally able to purchase 100,000 antibody tests from Anhui DeepBlue Medical Technology Co. for $600,000 on May 30, 2020.

Under the contract – organized by a broker known as Rallo Holdings, Ltd – Stevens was required to pay 75 percent of the cost upfront, totaling $481,125.00. The remaining balance of $118,875 would be due one month later.

“It was super scary,” Stevens recalled feeling about the massive purchase. “What we called it back then was ‘pay and pray’ because you had to pay for them, for the most part, upfront. It was one of those things that makes you go, ‘What’s the best decision here: not buy any tests and not have any here in the U.S., or buy them from the only country that magically has the formulas to produce these tests right now so that way we can at least try.”

While the “pay and pray” method had worked with other manufacturers, Stevens quickly realized that DeepBlue would be a different story. After a series of delays during which the Chinese company “held [Stevens’] money for a long time,” he said the tests finally arrived — but the trouble was just beginning.

Stevens said his company always conducted “sample validations on all tests to ensure good quality prior to using or distributing,” a standard that made AnyPlace MD “a preferred provider to many states and military customers.”

Using AnyPlace MD’s high inspection standards, Stevens discovered that DeepBlue’s tests were “terrible.”

According to Stevens, the tests had what he referred to as “phantom lines,” which are lines that make a negative test appear positive. Upon further inspection, Stevens’ company found that the tests were not put together properly, leading to inaccurate results.

Stevens immediately notified Rallo that the tests were defective and requested a refund.

Amid the chaos of the pandemic’s first weeks, in April 2020, the FDA warned that “some firms are falsely claiming that their serological tests are FDA approved or authorized, or falsely claiming that they can diagnose COVID-19.” At the time, the FDA provided The Texas Tribune with a list of companies that had received emergency use authorization. Anhui DeepBlue was not on that list, but the Chinese company was later added to an FDA list of tests that “should not be distributed.”

Read the full report HERE.



 

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