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
This recall is related to possible erroneous decoding of ean 13 barcodes used for operator and/or patient identification under specific conditions observed on the systems accu-chek inform ii meters and coaguchek xs pro monitors.
Model Catalog: 05060303001 (Lot serial: ALL LOTS); Model Catalog: 05060311001 (Lot serial: ALL LOTS); Model Catalog: 05530199190 (Lot serial: ALL LOTS)