기기

이름 분류 제조사 위험등급 국가 출처
ONLINE TDM Gentamicin. An in vitro diagnostic medical device (IVD)cobas c 501/502 modules Roche Diagnostics Australia Pty Limited Australia
cobas 8100 BRF and URF with software versions 02-xx. An in vitro diagnostic medical device (IVD) Roche Diagnostics Australia Pty Limited Australia
Sysmex XN-Series Automated Haematology Analysers. An in vitro diagnostic medical device (IVD). Roche Diagnostics Australia Pty Limited Australia
Elecsys Thyroid Stimulating Hormone (TSH) and Elecsys Parathyroid Hormone (PTH) (1-84) when used on the cobas e 602 module. An in vitro diagnostic medical device (IVD). Roche Diagnostics Australia Pty Limited Australia
Elecsys Anti-HAV assay run on the Elecsys 2010 and cobas e 411 analysers, cobas e 601/602 modules and Modular Analytics E-Module. An in vitro diagnostic medical device (IVD). Roche Diagnostics Australia Pty Limited Australia
Lysercell WDF 2 x 4L used on Sysmex XN-Series Automated Haematology Analysers. An in vitro diagnostic medical device (IVD). Roche Diagnostics Australia Pty Limited Australia
Sysmex XN-9000 Automated Haematology System. An in vitro diagnostic medical device (IVD). Roche Diagnostics Australia Pty Limited Australia
PreciControl Varia when used with Elecsys Parathyroid Hormone (PTH) assay on the cobas e 411 analyser. An in vitro diagnostic medical device (IVD). Roche Diagnostics Australia Pty Limited Australia
Homocysteine Enzymatic Assay used on Cobas Integra 400 plus/800 analysers and cobas c 501/502 & 701/702 modules. An in vitro diagnostic medical device (IVD). Roche Diagnostics Australia Pty Limited Australia
Tina-quant Haemoglobin A1c Gen.2 used with COBAS INTEGRA 400 plus analyser, COBAS INTEGRA 800 analyser and cobas c 501/502 modules. An in vitro diagnostic medical device (IVD). Roche Diagnostics Australia Pty Limited Australia
Rack Trays used with cobas, Modular Analytics and Urisys instruments/systems. An in vitro diagnostic medical device (IVD). Roche Diagnostics Australia Pty Limited Australia
Combur-Test and ChoiceLine 10 test kits (urine test strips). An in vitro diagnostic medical device (IVD) Roche Diagnostics Australia Pty Limited Australia
cobas 6800 system - cobas MPX, 96 tests and cobas MPX, 480 tests. An in-vitro diagnostic medical device (IVD). cobas MPX, 96 tests Roche Diagnostics Australia Pty Limited Australia
Vancomycin Assay (performed on cobas C and Modular Analytics P-Module) Roche Diagnostics Australia Pty Limited Australia
ONLINE TDM Gentamicin assay and Preciest TDM I Calibrator. An in vitro diagnostic medical device (IVD) Roche Diagnostics Australia Pty Limited Australia
Elecsys Estradiol Assay with Fulvestrant. An in-vitro diagnostic medical device (IVD) Clinical Chemistry and Clinical Toxicology Devices Roche Diagnostics Australia Pty Limited Australia
USB Communication Data Loss – Handheld Base Unit and Accu-Chek Inform II Base Unit Roche Diagnostics Australia Pty Limited Australia
cobas p 512 pre-analytical system. An in vitro diagnostic device (IVD) Roche Diagnostics Australia Pty Limited Australia
Reflotron Uric Acid (used with Reflotron Plus & Reflotron Sprint Single test chemistry systems) An in vitro diagnostic medical device (IVD) Roche Diagnostics Australia Pty Limited Australia
Sysmex XN and XN-L Series - All Sysmex XN analysers versions 16 to 19 Roche Diagnostics Australia Pty Limited Australia
Tina-quant Albumin. An in vitro diagnostic medical device (IVD) Roche Diagnostics Australia Pty Limited Australia
BenchMark ULTRA with software versions VSS 11.9 or higher, and DISCOVERY ULTRA clinical chemistry analysers (used for detecting and preparing tissue morphology and components). An in vitro diagnostic medical device (IVD). Roche Diagnostics Australia Pty Limited Australia
Roche Clinical Chemistry tests using NAD(H) or NADP(H) reaction. An in vitro diagnostic medical device (IVD). Roche Diagnostics Australia Pty Limited Australia
PreciControl ClinChem Multi 1 Lot No. 174787 & 174794 PreciControl ClinChem Multi 2 Lot No. 174801 & 174801(Potentially all lots are affected; this issue is easily detected as the QC will be elevated. Patient samples are not affected.) Roche Diagnostics Australia Pty Limited Australia
Bulk Loader Module for cobas p 471 centrifuge unit(Automated clinical analytical systems designed to analyse biological samples for in vitro diagnostic purposes) Roche Diagnostics Australia Pty Limited Australia