FDA (Devices) recall action 89757
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
There is a potential for misquantitation high results of negative samples.
There is a potential for misquantitation high results for negative samples.
The agency’s own wording, quoted from the enforcement report.
Abbott Molecular recalled Alinity m HBV Application Specification Files due to potential for incorrect high quantitation results on negative samples, which could affect test accuracy for hepatitis B virus detection.
Abbott Molecular is recalling the Alinity m HBV AMP Kit due to potential for falsely high results on negative samples. The kits are used for Hepatitis B virus testing in the US and internationally.