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 received an increased number of complaints related to the hemoblobin (hgb) parameter on the lh 750 and lh 780 analyzers including: hgb background failures hgb incomplete computations (...) and one customer observed false low hgb values. the investigation revealed that the issues may be related to variability in a component of the diluents which in turn may lead to a film coating the inside of the hgb cuvette. the issue is not observed with all analyzers.