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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Internal testing has confirmed a low absorbance with ptn flex lot fa5154 resulting in the potential for a positive or negative bias and imprecision across the ptn assay range. internal studies demonstrate the bias is variable across the assay range from 9-38%. the highest degree of bias is observed below the therapeutic range of 10-20 ug/ml (39.6-79.2 umol/l). the reagent blank absorbance for ptn lot fa5154 may also generate abnormal reaction flags. the issue may be detected by qc or failed calibrations. if undetected by qc it may manifest as inaccuracy or imprecision with patient samples.