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.
데이터 추가 비고
원인
Some packages of the replacement part piercer set #1 (part # 971-0583-5) used on xe-series analyzers have an incorrect piercer inside the box. the piercer set #1 is a consumable that is periodically replaced by the operator after a number of cycles on the xe-series automated hematology analyzers. a small number of the boxes labeled as containing a piercer set #1 contain the incorrect piercer that is used on another sysmex analyzer model.