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 is providing an update to all advia chemistry systems lactate dehydrogenase l-p (ldlp) and lactate dehydrogenase p-l (ldpl) assay instructions for use (ifus). the current advia chemistry systems lactate dehydrogenase ifus intended use section contains the following statements which will be removed: advia chemistry ldlp: they may also be used to monitor cancer therapy. advia chemistry ldpl: they may also be used to monitor extensive cancer and cancer therapy. the revised ifu intended use for both assays are listed below: advia chemistry ldlp: for in vitro diagnostic use in the quantitative determination of lactate dehydrogenase activity in human serum and plasma on advia chemistry systems. such measurements are used mainly in the diagnosis and treatment of myocardial and pulmonary infarction. advia chemistry ldpl: for in vitro diagnostic use in the quantitative determination of lactate dehydrogenase activity in human serum and plasma on advia chemistry systems. such measurements are used mainly in the diagnosis and treatment of myocardial and pulmonary infarction.