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 The regulator has identified the recall of the Alinity m SARS-CoV-2
AMP and the Alinity m Resp-4-Plex AMP test kits by unit Abbott
Molecular Inc as a Class 1 recall, the most serious type.
The agency in September issued a letter cautioning healthcare
providers and clinical laboratories of a potential for false
positive results with the two tests, and recommended they consider
retesting positive patient samples with another authorized COVID-19
test.
The tests require a software, which is used at the laboratories
where the samples are processed, to automate the mixing of
chemicals.
An overflow of one patient sample into another while mixing
chemicals with the samples could be related to the false positive
results, the FDA said on Thursday.
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 On Sept. 2, Abbott Molecular
issued a notice asking impacted customers to
consider all positive COVID-19 test results
presumptive until it was able to implement
software updates to correct the issue at the
customers' laboratory sites, according to the
FDA.
The agency said no deaths or adverse health
consequences have been reported from use of the
tests.
Abbott has a range of FDA-authorized COVID-19
tests, including antigen, molecular and
serology, which helped boost its revenue during
the peak of the pandemic last year.
(Reporting by Amruta Khandekar; Editing by
Devika Syamnath)
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