Medical device manufacturer, Abbott Laboratories Ltd, has issued a field safety notice concerning ARCHITECT Anti- HBc II Reagent Kit, with the following details:
According to the manufacturer, the affected product shows lower calibrator, control and sample relative light unit (RLU) values, potentially leading to reduced specificity and increased false reactive results. Internal testing showed specificity dropped to 99.2% which is below the package insert claim of 99.5% on a blood donor population. There is the potential for false reactive patient results but assay sensitivity is not impacted.
The manufacturer advises users not to use the affected lots and destroy any remaining inventory of these lots according to their laboratory procedures.
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 2 March 2015