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Ellume's COVID-19 coronavirus home test units are seen
at a digital diagnostics company in Australia, on Dec. 21. 2020.
(Patrick Hamilton/AFP via Getty Images)





AMERICA

FDA Alert:
2 Million At-home COVID-19 Tests Recalled
Over False Positives


BY JACK PHILLIPS
November 12, 2021
Updated: November 14, 2021



The U.S. Food and Drug Administration (FDA) confirmed Thursday it is recalling
some 2 million Ellume at-home COVID-19 testing because they can produce
“false positives” due to a manufacturing defect.

The firm first informed the federal regulatory agency about the defect in some
lots in October. But on Wednesday, the FDA said it identified additional lots that
were affected by the manufacturing defect, made between Feb. 24, 2021,
and Aug. 11, 2021.

To date, about 35 false positives from the COVID-19 tests were reported to
the FDA. No deaths have been reported related to the test, according to the
agency.

A “false positive” indicates that an individual has contracted the CCP
(Chinese Communist Party) virus, which causes COVID-19, when they
actually do not.

The FDA noted that false positives could lead to “delayed diagnosis or
treatment for the actual cause of the person’s illness, which could be
another life-threatening disease that is not COVID-19” or receiving
“unnecessary COVID-19 treatment from a health care provider,” which
may “result in side effects.”

Another problem, the FDA noted, is isolation, including monitoring household
or close contacts for symptoms, limiting contact with family or friends,
and missing school or work.”

Underscoring the severity of the issue, the FDA said it “identified this as
a Class I recall, the most serious type of recall … use of these tests may
cause serious adverse health consequences or death.”

The antigen test detects proteins from the CCP virus from a nasal sample,
and it’s available without a prescription for use by people aged 2 years and
older. It also comes with an analyzer that connects with a smartphone app
to show users to perform the test and understand the test results.

Ellume has recalled 2,212,335 tests in the United States to date.
Earlier this year, the Australia-based firm announced it had about
200,000 of its tests.

The Biden administration had signed a $231 million deal with Ellume,
which received approval to produce its tests under the Trump administration
last year.

In October, Dr. Sean Parsons, Ellume’s chief executive, announced that
the firm had created more safeguards to stop the problem from occurring again.

“I’m very sorry that this has happened,” he told the New York Times at the time.
“We’re all about chasing accuracy, and to have these false positives is disappointing.”

And a spokesperson said that the “root cause” of the issue was identified.
The company is already shipping new products inside the United States,
the spokesperson added to the NY Times.




The Epoch Times has contacted Ellume for comment.