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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The sample presentation unit ("spu") may push two sample racks instead of one into the sample presentation area when the gap between racks is obstructed with foreign material such as tape. beckman coulter has received a report of results that were associated with incorrect patient identifications when two sample racks advanced into the sample presentation area in one push. the first rack of the two was not scanned. this is referred to as a "pushed pair.".