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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Siemens healthcare diagnostics has confirmed the advia chemistry triglyceride concentrated reagent (trig_c) does not meet instructions for use (ifu) linearity claim at the upper limit of the assay range as it approaches end of shelf life for lots 348297 and 359932. internal testing demonstrated that a patient bias (-12% to -15%) may be seen at concentration levels between 450 to 550mg/dl (5.085 - 6.215mmol/l). linearity is reduced by approximately 30% at higher triglyceride concentrations up to 1200mg/dl (13.56mmol/l). quality control (qc) material may not detect this issue depending on the concentrations used during qc testing.