Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
데이터 추가 비고
원인
Under certain conditions myla software when connected to a vitek 2 system and to a laboratory information system (lis) allowing the re-use of speciment id prensents the potential to link a result from vitek 2 to the wrong patient and then upload those results to the lis.
Model Catalog: 417191 MASTER 4.1 CLINIC (Lot serial: Myla Clinical 3.X to 4.1 ML350); Model Catalog: 416546 MASTER 4.0 CLINIC (Lot serial: Myla Clinical 3.X to 4.1 ML350); Model Catalog: 415358 MASTER 3.2 CLI DL380 (Lot serial: Myla Clinical 3.X to 4.1 ML350); Model Catalog: 419072 CLINICAL V3.X TO V 4.1 ML350 SERVER (Lot serial: Myla Clinical 3.X to 4.1 DL380); Model Catalog: 419071 CLINICAL V3.X TO V4.1 DL380 SERVER (Lot serial: Myla Clinical 3.X to 4.1 DL380); Model Catalog: 417191 MASTER 4.1 CLINIC (Lot serial: Myla Clinical 3.X to 4.1 DL380); Model Catalog: 416546 MASTER 4.0 CLINIC (Lot serial: Myla Clinical 3.X to 4.1 DL380); Model Catalog: 415358 MASTER 3.2 CLI DL380 (Lot serial: Myla Clinical 3.X to 4.1 DL380); Model Catalog: 419072 CLINICAL V3.X TO V 4.1 ML350 SERVER (Lot serial: Myla Master DVD 4.1 Clinique); Model Catalog: 419071 CLINICAL V3.X TO V4.1 DL380 SERVER (Lot serial: Myla Master DVD 4.1 Clinique); Model Catalog: 417191 MASTER 4.1 CLINIC (Lot serial: Myla Master DVD 4.1 Clinique); Model C