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 has determined that if the bleach cycle is interrupted or aborted the dxh 500 does not provide any warning message to the operator and the system does not sufficiently flush out residual bleach prior to sample analysis. should a bleach cycle get interrupted the subsequent software recovery to perform a diluter reset may not be sufficient to prevent the first immediate sample run from being affected. patient results may be impacted due to residual bleach in the diluter when a sample is processed immediately after a bleach cycle is interrupted.