Abbott Labs recalls two COVID test kits after false positives

pharmafile | October 15, 2021 | News story | Medical Communications  

A unit of Abbott Laboratories is recalling two COVID-19 lab test kits over concerns they can potentially issue false positives, the FDA announced on Thursday.

The tests that have been recalled are the Alinity m SARS-CoV-2 AMP and the Alinity m Resp-4-Plex AMP, from unit Abbott Molecular Inc, and have been recalled as a Class 1 recall, the most serious type.

One of the tests is only for COVID and the other can detect the coronavirus alongside respiratory syncytial virus and influenza A and B. The former received its initial emergency use authorisation from the FDA in May 2020 – an authorisation that was revised and upheld as recently as last month – while the multiuse test was authorised in March of this year.

Both tests are authorised for use only in clinical labs certified to perform moderate- or high-complexity tests.

In September the FDA 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 authorised COVID-19 test.

The Abbott 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 2 September 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.

The agency said no deaths or adverse health consequences have been reported from use of the tests.

Abbott has a range of FDA-authorised COVID-19 tests, including antigen, molecular and serology, which helped boost its revenue during the peak of the pandemic last year.

Kat Jenkins

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