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ADVIA Chemistry Systems (using Trinder and Trinder-like assays). An in vitro diagnostic medical device (IVD) Assays affected: Cholesterol_2, Cholesterol_c, Enzymatic Creatinine_2, Glucose Oxidase, Triglycerides_2, Triglycerides_2 concentrated, Uric Acid, Uric Acid concentrated reagents, Fructosamine.LDL Cholesterol Direct, Direct HDL Cholesterol, Glucose Oxidase, Concentrated reagents. 의 리콜
2016-03-24
Australia
DHTGA
Dimension and Dimension Vista Clinical Chemistry Systems. An in vitro diagnostic medical device (IVD) Assays affected: Triglycerides, Enzymatic Creatinine, Automated HDL Cholesterol, Uric Acid and HDL Cholesterol 의 리콜
2016-03-24
Australia
DHTGA
MobileDiagnost wDR Rel1 and 2 (general purpose mobile digital x-ray system) 의 리콜
2016-03-24
Australia
DHTGA
TCAutomation System with Thermo Scientific Recapper (used with VITROS Automation Solutions). An in vitro diagnostic medical device (IVD) 의 리콜
2016-03-24
Australia
DHTGA
Acuson SC200 ultrasound systems 의 리콜
2016-03-24
Australia
DHTGA
Fetch 2 Aspiration Catheter (used for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature) 의 리콜
2016-03-24
Australia
DHTGA
Acuson 2000 ultrasound system (with structural foam core). 의 리콜
2016-03-24
Australia
DHTGA
ME DPHC 0001 deltastream HC, 230V (Cardiopulmonary bypass system heating/cooling unit) 의 리콜
2016-04-07
Australia
DHTGA
Dimension Vista 500/ Dimension Vista 1500 Intelligent Lab Systems, software versions V. 3.6.1 SP1 or V. 3.6.2. An in vitro diagnostic medical device (IVD) 의 리콜
2016-03-30
Australia
DHTGA
Military Trauma & Haemorrhage Wound Dressing, size 10 x 17cm 의 리콜
2016-04-14
Australia
DHTGA
ID Anti-N and ID Anti-M/N. An in vitro diagnostic medical device (IVD) 의 리콜
2016-04-07
Australia
DHTGA
Artis zee Systems with generator A100Plus or Artis zeego Systems with software version VC21B. (fluoroscopic angiographic x-ray systems) 의 리콜
2016-03-31
Australia
DHTGA
Vaxcel and Xcela PICC with PASV Valve Technology/Kits, BioFlo PICC Triple Lumen with Endexo and PASV Valve Technology/Kits 의 리콜
2016-04-08
Australia
DHTGA
AutoSPECT Pro Reconstruction application on Extended Brilliance Workplace NM software version 2.0(used to process, analyse, and display medical images/data obtained from other diagnostic devices, including gamma cameras) 의 리콜
2016-04-06
Australia
DHTGA
AutoSPECT Pro Reconstruction application on Intellispace Portal software versions 5.0, 6.0 and 7.0 의 리콜
2016-04-01
Australia
DHTGA
10mm Direct Drive Clip Applier (Used for ligation of tubular structures or vessels in laparoscopic and general surgical procedures) 의 리콜
2016-04-05
Australia
DHTGA
CELL-DYN Emerald Cleaner. An in vitro diagnostic medical device (IVD) 의 리콜
2016-04-05
Australia
DHTGA
EZee-Nest Insert Cups used with ADVIA Centaur CP. An in vitro diagnostic medical device (IVD) 의 리콜
2016-04-05
Australia
DHTGA
ARCHITECT Estradiol Reagent. An in vitro diagnostic medical device (IVD) 의 리콜
2016-04-05
Australia
DHTGA
PneumoSure XL High Flow Insufflator (Used to create a cavity by insufflating CO2 during diagnostics and/or therapeutic laparoscopy) 의 리콜
2016-04-04
Australia
DHTGA
Oxoid Antimicrobial Susceptibility Testing Discs - Ticarcillin/Clavulanic Acid (TIM85 Timetin). An in vitro diagnostic medical device (IVD) 의 리콜
2016-04-05
Australia
DHTGA
Mizuho General Purpose Operating Table 의 리콜
2016-04-11
Australia
DHTGA
Gene Amplification Reagent – Lynoamp BC. An in vitro diagnostic medical device. 의 리콜
2016-04-05
Australia
DHTGA
Somatom Force with software versions, VA50A and VA50A_SP2 with paediatric kernel Hp38 (Computed Tomography (CT) system) 의 리콜
2016-04-05
Australia
DHTGA
Aisys and Aisys CS2 Anaesthesia machines with the optional Vacuum Suction Function 의 리콜
2016-04-08
Australia
DHTGA
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