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.
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Ortho-clinical diagnostics inc. (ocd) is informing users of a software anomaly regarding microslide reagent management on the vitros 51 fs chemistry system (software version 2.8 & below). ocd has confirmed two instances where a vitros microslide cartridge was misidentified. both instances occurred when an operator accessed slide supply 1 (ss1) before the green indicator light was illuminated and subsequently proceeded to load a slide cartridge into slide supply 2. in each occurrence the loaded cartridge in slide supply 2 was misidentified. if this anomaly occurs it is possible for vitros 51 fs systems to process samples with a cartridge other than the intended cartridge potentially leading to erroneous patient results.