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 that the advia centaur systems myoglobin assay is not meeting the analytical sensitivity claim of < 3 ng/ml (ug/l) as specified in the advia centaur myoglobin instructions for use (ifu) for all in-date reagent lots when evaluated with calibrator u kit lots ending in 63 and 64. values up to 12 ng/ml (ug/l) were observed. siemens' investigation has identified that the calibrator u kit lots ending in 63 or 64 have drifted from the internal standardization causing a positive shift in results.