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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Immucor transplant diagnostics inc. is investigating a single instance of false positive reactivity of probe dqb253 associated with an allele pair of dqb1*03:03:02:01 dqb1*03:04:01. a false positive result causes the exclusion of dqb1*03:03:02:01/ 03:04:01 as a possible allele combination. the false positive reactivity is only observed in a dqb1*03:03:02:01 dqb1*03:04:01 heterozygous combination. other combinations with dqb1*03:03:02:01 or dqb1*03:04:01 are not affected.