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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As per the manufacturer during a complaint investigation it was determined that the abx pentra 400 does not provide a low or high out of linearity range flag for ise results (i.E. sodium chloride and potassium). the only flag that is present in these situations is the ref-range_low or _high analysis flags and an "l" or "h" flag on the patient report. there was no alarm informing the user that the value was outside of the instrument's linearity limits. the lack of an out of linearity range flag without any indication that the results may actually be invalid due to the linearity limits being exceeded. this is a software design oversight for the abx pentra 400 i.S.E. module instruments.