Alere Cholestech LDX hsCRP Cassette (An in vitro medical device (IVD) used in the quantitative determination of C-reactive protein in whole blood or serum )Catalogue Number: CT12-807Lot Numbers: 274632 & 281847/14ARTG Number: 160951
Alere Cholestech LDX Multianalyte Control (An in vitro diagnostic medical device used to monitor the performance of total cholesterol (TC), high density lipoprotein (HDL), triglycerides (TRG), glucose (GLU), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) test procedures on the Alere Cholestech LDX System)Catalogue Number: CT88769Lot Numbers: C2572, C2572A, C2593 & C2593AARTG Number: 160951
epoc BGEM Test Card (blood gas, electrolyte and metabolite test card panel), An in vitro diagnostic medical device (IVD).Catalogue Number: CT-1004-00-00Lot Numbers: 07-12289-00 & 07-01263-00ARTG Number: 198588
SJM Confirm External Patient Activator Model DM2100ASupplied separately or together with a SJM Confirm Implantable Cardiac Monitor (ICM) DM2100 or DM2102.ARTG Numbers: 160466
ARCHITECT STAT High Sensitive Troponin-I Calibrators and ControlsARCHITECT STAT High Sensitive Troponin-I Calibrators, LN 3P25-01Lot number: 24057UI000Expiry 9 July 2013ARCHITECT STAT High Sensitive Troponin-I Controls, LN 3P25-10Lot number: 24058UI00, Expiry 8 July 2013Lot number: 26218UI00, Expiry 11 November 2013
Phosphorus Reagent. An in vitro diagnostic medical device (IVD). (Used for the quantitation of phosphorus in human serum, plasma or urine)Used for the quantitation of phosphorus in human serum, plasma or urine.List Number: 7D71-22Lot Numbers: 64736UN12, 03991UN13, 51611UN13 List Number: 7D71-31Lot Numbers: 74805UN12, 03992UN13
i-STAT PT/INR Cartridge (prothrombin time test used for monitoring patients receiving oral anticoagulation therapy) (An in vitro diagnostic medical device (IVD))List Number: 3P89-24Lot Numbers: C103139 to and including C13270AARTG Number: 213851
FreeStyle Lite Blood Glucose Test Strips (used with FreeStyle Papillon Mini Blood Glucose Meters). An in vitro diagnostic medical device (IVD)Product Number: 70984.70Lot Numbers: 1366540, 1366621
St. Jude Medical ICD/CRT-D devices programmed to a single VF detection zone with Merlin Programmer software version 17.2.2 rev. 0Affected ICD/CRT-D devices: Current/Promote/AnalyST, Unify/Fortify, Assura and Ellipse families Multiple ARTG numbers for ICD/CRT-D devicesARTG number for the Merlin Programmer: 124262
ARCHITECT Intact Parathyroid (PTH) Assay. An in vitro diagnostic medical device (IVD) List Number: 8K25 Reagent List Numbers: 8K25-20, 8K25-25 Calibrator List Numbers: 8K25-01Control List Numbers: 8K25-10Multiple Lot Numbers affected
VerifyNow IIb/IIIa 25 Test and VerifyNow IIb/IIIa 10 Test (An in vitro Diagnostic Medical Device (IVD))VerifyNow IIb/IIIa 25 Test Catalogue No. AC85011 Lot: WC0180C Lot Expiry: 21/10/2013VerifyNow IIb/IIIa 10 Test Catalogue No. AC85310 Lot: WC0182D Lot Expiry: 8/7/2014
Lipase Reagent (diagnostic good for the quantitation of lipase in human serum or plasma)Lot Numbers: 43827UQ12, 43819UQ03, 44449UQ05, 44127UQ06, 44334UQ07, 43994UQ07, 44596UQ08, 44775UQ09, 44930UQ11
Alere INRatio2 PT/INR Heparin Insensitive Test StripsCatalogue Numbers: HS099007EU, HS99007G1, HS099008EU, HS99008G1 All lots within expiryARTG Numbers: 162331 and 216755