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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One complaint regarding this issue has been received. one customer complaint (pr184220) was recorded. a customer reported that the reactivity for lanes 13 27 30 39 and 40 was negative for the dpb1*99:01 allele when the labeling of the dpb1 ssp unitray 12 tests kit (451606d) indicates the reactivity should be positive. the labeling discrepancy may lead to potentially mistyping a dpb1*99:01 allele (population frequency < 0.01%) as a dpb1*39:01 allele. after investigation it was determined that the dpb1 ssp unitray with taq 12 tests kit (451616d) and the allset gold dpb1 high res ssp kit (54070d) are also affected by the labeling issue since they contain the same primer present in the dpb1 ssp unitray 12 tests kit (451606d). life technologies confirmed the issue on 11 march 2015.