By Katabella Roberts
October 6, 2021 Updated: October 6, 2021
Ellume COVID-19 Home Test. (Ellume)
Nearly 200,000
at-home COVID-19 tests in
the United States have been recalled by Australian medical tech
manufacturer Ellume after the company identified that they were producing
incorrect positive results. Ellume was
given an emergency
authorization in December 2020 by the U.S. Food and Drug Administration
(FDA) to supply the COVID-19 Home Test for nonprescription use by
symptomatic and asymptomatic individuals aged 2 years and older. The home tests
deliver results within 15 minutes. The
Biden administration signed a $231.8 million deal with the company, which
initially got the green light from the Trump administration in 2020, to
produce more than 633,000 tests kits per day (19 million per month), of which
8.5 million units were reserved for Americans. But
the FDA
on Oct. 5 stated that it’s “alerting test users, caregivers,
health care personnel, and the public of the potential for false positive
results with certain lots of the Ellume COVID-19 Home Test, due to a recently
identified manufacturing issue.” “For
these tests, a ‘false positive’ is a test result that indicates that a person
has the virus when they do not actually have it. Negative results do not appear
to be affected by the manufacturing issue,” the notice reads. The
FDA added that it’s working closely with Ellume to “assess the company’s
additional manufacturing checks and other corrective steps to help ensure that
the issue is resolved.” In
the meantime, test users are being asked to check if their home tests are
included in the recall by comparing the lot number on the test carton to the
lot numbers on the company’s website. MOST
READ
Users
are also asked to contact their health care provider or urgent care facility to
request a COVID-19 molecular diagnostic test if they have received a
positive result with the potentially defective at-home test within the past two
weeks, and haven’t yet had a follow-up with a health provider to confirm the
positive result. “You
should not assume that you had COVID-19 or have immunity to COVID-19,” the FDA
stated, while recommending at-home test users still take precautions in line
with the Centers for Disease Control and Prevention recommendations. A
spokesman for Ellume told
AFP
on Oct. 6 that 195,000 out of 3.5 million tests that were shipped to the United
States had been affected. RELATED The Real Effects of COVID-19 Are Psychological Some
of the recalled tests were provided to the U.S. Department
of Defense, according to a report by The New York Times. The
company said in a statement on its website that it had identified the incidence
of false positives in specific lots of the tests following a thorough
investigation. “We
offer our sincere apologies for the stress or difficulties people may have
experienced due to a false positive result. We have and will continue to work
diligently to ensure test accuracy, in all cases,” the statement reads. Ellume
is one of several companies that has received emergency use authorization by
the FDA for rapid antigen COVID-19 tests, and the recall comes amid
growing demand for home tests in support of the Biden administration’s efforts
to combat COVID-19. On
Oct. 4, the FDA granted emergency use authorization for ACON
Laboratories’ Flowflex COVID-19 Home Test, which can
be used at home without a prescription. ACON,
a San Diego-based company, plans to produce more than 100 million
tests per month, and 200 million per month by February 2022, the
FDA said in a statement. Caden Pearson contributed to this report. (The Epoch Times)
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