Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Medical device manufacturer, Abbott Ireland Diagnostics Division, has issued a medical device safety alert concerning its Alinity i Anti-HBs Reagent Kit [List number: 07P8952; Lot number: 51441FN00] [HKMD numbers: 190289].
The manufacturer has identified that some cartridges within Alinity i Anti-HBs Reagent Kit, LN 07P8952, lot 51441FN00, have reduced volume in the microparticle bottle, which will result in aspiration error message codes.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 29 Jan 2024