(Reuters) – A unit of Abbott Laboratories is recalling two COVID-19 laboratory test kits as they can potentially issue false positive results, the U.S. Food and Drug Administration (FDA) said on Thursday.
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.
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.
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