Medical device manufacturer, Abbott Laboratories issued a safety alert concerning certain lots of ARCHITECT CA 19-9XR reagent.
Abbott has confirmed that these six ARCHITECT CA 19-9XR reagent lots are demonstrating a shift up in patient results. An internal investigation is in process. Initial indications suggest that the issue is caused by the conjugate component as all lots identified above share the same conjugate component.
This issue may impact patient management when affected lots are used in monitoring of patients. Therefore, Abbott advised users to stop using the affected units and destroy any remaining inventory of the lots listed above.
According to the local supplier, the affected products have been distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted 4 June 2012