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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Internal investigation has demonstrated that in specific cases when a card is processed in and ejected from a slot number greater than 15 or 30 (all vitek 2 compact reader carousels contain 60 physical slots) respectively the final data packet for the card fails to be accepted by the computer and the isolate status remains at "preliminary". when the anomaly occurs subsequent data for current and future cards will not be transferred to the computer until the offending data packet is removed. since the card has completed processing as evidenced by the card ejection from the vitek 2 compact reader the results indicated in the lab report are the final results. as the card data for the ejected card will be lost after record removal it is recommended the user print the lab report prior to removal of the record.