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
Leica biosystems recently became aware that the novocastra liquid mouse monoclonal antibody renal cell carcinoma marker lots 6036120 6032345 and 6023543 do not function as intended up to the expiry date on the product labelling and subsequently may lead to inadequate or weak tissue staining. there is a link between the age of the product and staining intensity. when used according to the instructions for use with appropriate positive controls the failure to adequately stain would be apparent to the user on the control tissue and on the patient tissue. this issue is limited to this product and the lot numbers listed.