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 (pr182500) was recorded. a customer reported a discrepant test result between ssp rssop and secore test methods. the secore and rssop test result of the dna sample was an a*30:16 a*33:03 heterozygous typing but the ssp test result allset gold a high res ssp (54010d) lot 012 1544269 was a*30:01 a*33:03 heterozygous typing based on product labeling. the labeling discrepancy may lead to potentially mistyping an a*30:16 allele (population frequency < 0.01%) as an a*30:01. also the a high res ssp unitray 10tests (4729010) a high res ssp unitray w/taq10 (4729110) a-02 ssp unitray 12 tests (470204d) and allset gold a*02 high res ssp (54110d) are affected by the labeling issue since they contain the same primer present in the allset gold a high res ssp kit. in addition to the a*30:16 allele that may be mistyped as an a*30:01 allele the investigation showed that the labeling for the reactivity of the following two alleles should be changed from positive to negative: a*03:09 (population frequency of <0.01%) a*11:06 (population frequency of 0.01%) no complaints have been received on these two alleles but updating the reactivity based on the current information may prevent future complaints on them. life technologies confirmed the issue on 19 february 2015.