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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Radiometer has recently become aware that supplementary inserts for some lots of s7335 (autocheck 3+ level 1) distributed in connection with the release of sofware version 6.16 for the abl800 series analyzers state an incorrect control range for pco2 in "abl810/820/830 sw more than v6.16" column. on the incorrect inserts both the low and high limits are offset by +1.3 mmhg for all affected lots. this also applies to the value in the barcode in the insert. the bar code is used to upload the values to the analyzer.