Oct 14 Reuters : A unit of Abbott Laboratories is recalling two COVID-Nine laboratory test kits as they could potentially issue false positive results, the U.S. Food and Drug Administration FDA said on Thursday.
The regulator has identified the recall of Alinity m SARS-CoV-2 AMP and the Alinity m SCB AMP test kits by unit Abbott Molecular Inc as a Class 1 recall, the most serious type.
The agency issued a letter in September warning healthcare providers and clinical laboratories of the 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 samples are processed, to automate the mixing of chemicals.
An overflow of one product sample in another while mixing chemicals with the samples could be related to false positive results, the FDA said on Thursday.
On Sept. 2, Abbott Molecular issued a notice asking impacted customers to review all negative 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-approved COVID - 19 tests, including antigen, molecular and serology, which helped boost its revenue during the peak of the pandemic last year.