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
Ig-a reagent lots m812614 and m902345 contain an unidentified cross reacting antibody that may yield falsely high ig-a results in survey samples for immunoglobulins which are formulated with ig-m monoclonal antibodies.
Model Catalog: 467920 (Lot serial: Lot Number M182164); Model Catalog: 467920 (Lot serial: Lot Number M902345); Model Catalog: 467920 (Lot serial: Lot Number M909608); Model Catalog: 467920 (Lot serial: Lot Number M904324); Model Catalog: 467920 (Lot serial: Lot Number M810152); Model Catalog: 467920 (Lot serial: Lot Number M808240)
제품 설명
SYNCHRON System(s) Immunoglobulin A (Ig-A) Reagent