5mL Reaction Vessels used with the m2000sp Instrument. An in vitro diagnostic medical device (IVD)List Number: 04J71-20Lot Numbers: 56944001, 57026001, 57059001 and 57673001
St. Jude Medical Ellipse VR/DR Implantable Cardioverter Defibrillators (ICDs)Models: CD1277 (-36 and -36Q) , CD1377 (-36, -36Q, -36C and -36QC), CD2277 (-36 and -36Q), CD2377 (-36, -36Q, -36C and -36QC) Serial Numbers: beginning with “1” that are below 1132470, beginning with the number “7” that are below 7126267 and all serial numbers beginning with an “8” are affected.ARTG Numbers: 207181, 207182, 207183, 207184, 207185, 207186, 207187, 207189, 202934, 202938, 198821, 198822
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