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 These tests have not been authorized, cleared or approved by the FDA
for distribution or use in the United States, the health agency
said, adding that they may show false results.
The warning was issued against unauthorized versions of Celltrion
USA Inc's DiaTrust COVID-19 Ag Rapid Tests, SD Biosensor Inc's
STANDARD Q COVID-19 Ag Home Test , and ACON Laboratories' Flowflex
SARS-CoV-2 Antigen Rapid Test.
The authorized versions of the tests can continue to be used, but
consumers should compare the packaging to make sure they do not buy
unauthorized tests, the FDA said.
The unauthorized Acon test comes in blue packaging, SD Biosensor in
a white and magenta box and Celltrion's in green and white
packaging, according to the agency.
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 The FDA has not received reports of injuries,
adverse health consequences or death associated
with the use of these unauthorized tests.
All three companies have initiated a recall for
all unauthorized tests that were distributed in
the United States.
Antigen tests require a nasal or throat swab and
can produce results more quickly than molecular
tests, which detect genetic material in the
virus. However, antigen tests are considered
less accurate.
(Reporting by Mrinalika Roy in Bengaluru;
Editing by Devika Syamnath)
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