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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Beckman coulter inc. has identified four issues with the unicel dxh 800 coulter cellular analysis system: 1.Specimen tubes may fall out of a type a cassette when the analyzer inverts the cassette in the mixing station or when an operator manually inverts a cassette. 2.The dxh 800 may fail to meet the carryover specification for the wbc differential (diff) when the wbc is greater than 70 x 103 cells/ul (70 x 109 cells/l). 3.The dxh 800 may fail to meet the carryover specification for nrbc% when the wbc is greater than 50 x 103 cells/ul (50 x 109 cells/l). 4.The handheld barcode scanner does not read barcode labels using nw 7 symbology.