Abbott Labs unit recalls two COVID-19 lab test kits – FDA

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October 14 (Reuters) – A unit at Abbott Laboratories (ABT.N) is recalling two COVID-19 lab test kits because they can potentially issue false positive results, the US Food and Drug Administration (FDA) said on Thursday. United.

The regulator has identified the recall of the Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP test kits by the Abbott Molecular Inc unit as a Class 1 recall, the most serious type.

The agency issued a letter in September warning healthcare providers and clinical labs of a potential false-positive results with both tests, and recommended that they consider retesting samples from positive patients with another. COVID-19 test authorized.

The tests require software, used in laboratories where samples are processed, to automate the mixing of chemicals.

An overflow from one patient sample into another when mixing chemicals with the samples could be linked to the false positive results, the FDA said Thursday.

On September 2, Abbott Molecular issued a notice asking affected customers to consider all positive COVID-19 test results as presumptive until it is able to implement software updates to correct the issue. at customer lab sites, according to the FDA.

The agency said no deaths or adverse health consequences had been reported as a result of using the tests.

Abbott offers a range of FDA-cleared COVID-19 tests, including antigenic, molecular, and serological, which helped boost revenue at the height of the pandemic last year.

Reporting by Amruta Khandekar; Editing by Devika Syamnath

Our Standards: Thomson Reuters Trust Principles.


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