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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During an internal complaint investigation for problem report pr#135598 the reactivity assignment in our human oligotyping software (hos) program for a32:04 allele in primer mix pm019e was determined to be incorrect. the catalog and lot numbers of the products listd above have been identified to be affected by the incorrect reactivity assignment. the kits would produce an incorrect low resolution typing or mistyping result of a*02 a*03 alleles when testing a sample which has the a32:04 allele. the user would be unaware of the incorrect type unless they confirm the sample typing by another method therefore this would be considered a mistype.