Medical device manufacturer, Abbott Molecular Inc., has issued a Field Safety Notice on Abbott Molecular Bar Code Scanner User's Guide List Number: 6L-88-03, 6L88-04, 6L88-05, 6L88-06, 6L88-07, 6L88-08, 6L88-09.
According to the manufacturer, internal investigation has identified that within the User's Guide, the section Modifying the Keyboard Format for Bar Code Scanner LN 6L89-01 contains incorrect bar codes that can prevent the correct configuration of the bar code scanner language format.
The manufacturer explained that incorrect Bar Code Scanner language configuration could result in the keyboard and bar code scanner not having the same language formats. This could potentially lead to incorrect patient sample identification. Independent of this language configuration issue, the Bar Code Scanner is working as expected.
The local supplier confirmed that scanners with the affected list numbers have not been distributed in Hong Kong. If you are in possession of the products, please contact your supplier for necessary actions.