Eon/Eon C/ Eon Mini/ Prodigy Neurostimulation Systems and Octrode/ Quattrode Percutaneous Leads and AccessoriesEon Neurostimulation System – ARTG 127126Eon C Neurostimulation System – ARTG 158502Eon Mini Neurostimulation System – ARTG 154912Prodigy device - currently is supplied in Australia under the Special Access Scheme (SAS)Octrode Percutaneous Leads - ARTG 132097Quattrode Percutaneous Leads – ARTG 131944
RF enabled St. Jude Medical Ellipse, Fortify Assura, Unify Assura, and Quadra Assura Implantable Cardioverter Defibrillators (ICDs) and Assurity and Allure Pacemakers when used with Merlin@home RF Remote Monitoring Transmitter Model EX1150All model numbers affected ARTG Number (Merlin@home Remote Monitoring System): 161670
i-STAT PT/INR Cartridges(prothrombin time test)List Number: 03P89-24Lot Number: All lots from S15007 to S15026 inclusive and All lots from T15037A to T15076A inclusiveARTG Number: 213851
ARCHITECT B12 Reagent kit7K61-35 lot 53921UI00 (Expiry 20 March 2016)7K61-25 lot 50957UI00 (Expiry 17 January 2016) 7K61-35 lot 50956UI00 (Expiry 17 January 2016) UDI Number- Not applicable ARTG Number: 186731
Absorb Bioresorbable Vascular Scaffold (BVS) System (Bioresorbable balloon expandable scaffold with bioresorbable polymeric drug coating mounted on a balloon dilatation catheter)All sizesARTG Number: 214148
Acetaminophen (Paracetamol) Reagent (used with L3K Assay in conjunction with the Architect cSystem Analyser). An in vitro diagnostic medical device (IVD)Sekisui List Numbers: 506-10 and 506-30Abbott List Number: 3R11-20Multiple lot numbers and expiry datesARTG Number: 224545
MitraClip System (Product Number # MSK02ST) containing the Clip Delivery System (Part number # CDS02ST) and the Steerable Guide Catheter (Part number # SGC01ST)(Used for reconstruction of the insufficient mitral valve through tissue approximation)Lot numbers: 50714U1 and higherARTG numbers:177709 and 189720
ARCHITECT STAT High Sensitive Troponin-I Reagent Kit. An in vitro diagnostic medical device (IVD)100 Test KitList Numbers: 3P25-25, 3P25-26Multiple Lot Numbers affected500 Test KitList Numbers: 3P25-35, 3P25-36Multiple Lot Numbers affectedARTG Number: 208227