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
The peloris ii tissue processor potentially has a faulty impellor. this potenial non-conformance has the capability to lead to reagent carry-over from one processing step to another. the non-conforming impellors have a faulty seal which could result in reagent seeping into and out of the impellor cavity during tissue processing. the total volume of reagent that could seep uncontrollably in and out of the impellor cavity is less than 1ml.