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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An extrapolation in the innovance d-dimer ous setting can lead to false negative (as well as to false positive) results on the sysmex cs-systems. the issue may only occur under the following conditions: - the initial result is falsely flagged with an antigen excess error that triggers an automatic remeasurement in a 1/19 dilution. and - the raw signal of the remeasurement is below the limit of blank (lob) of the method. under such conditions the low remeasurement raw value may be strongly affected by the signal noise of the optical system and can generate an erroneous low reading. the raw value will be corrected by the dilution factor and can be deduced from calibration curve in a false low range.