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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Currently the prealbumin reagent osr6175 does not meet the ifu lipemic (intralipid) interference claim of "no significant interference up to 500 mg/dl intralipid". in-house studies have demonstrated that the effect of intralipid on the prealbumin reagent varies and has been observed to cause a maximum negative interference of -27% up to 500 mg/dl intralipid on prealbumin recovery.