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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A customer reported that in allset+ gold a high res ssp kit lot 012 1608823 the reactivity for lane 86 was negative for an a*03:20 allele when the labeling indicates the reactivity should be positive. also the a high res ssp unitray kits are affected by this complaint since they contain the same reagents as the allset+ gold a high res ssp kits. the labeling discrepancy may lead to potentially mistyping an a*03:20 allele (population frequency < 0.01%) as an a*03:01.