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. has confirmed hla-drb1 probe 091 has been designed with the incorrect sequence. as a result the probe is not expected to react with any alleles including the three rare alleles for which it was designed to detect: drb107:20 and 11:86 and 13:16. analysis with probe 091 as a false negative does not cause a change in serological typing or level of resolution.