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
Issue # 1: manufacturer received complaints for samples not processing without notification on the dimension vista 500 or dimension vista 1500 using software versions 3.6.1 in most cases user action of pause / cancel pause is effective in restoring lane operation and the samples will resume processing. however in a few cases it was necessary to shutdown the instrument software and restart to recover. in all cases the affected samples are resubmitted and run successfully. issue # 2: manufacturer received complaints for unexpected less than lower assay range (