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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Customers have been experiencing a higher frequency of "above assay range" flags on patient samples with the dimension? hb1c method. upon dilution the result is usually well within the range of the assay. some customers understand the issue is hemoglobin being above the assay range of > 25 g/dl and have verified on an independent system that hemoglobin on affected samples are < 25 g/dl. some customers have experienced a high bias on us cap survey samples (2012 gh2-b) with the hb1c method. cap samples that failed are in the normal range of the method.