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.
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Beckman coulter has confirmed sporadically lowered aptt results outside of the clia allowable error limit of 15% when using these il locked test groups.
Model Catalog: 0000880011 (Lot serial: 03060101 to 09100677); Model Catalog: 0000990011 (Lot serial: 00040105 to 09031882); Model Catalog: 0000880311 (Lot serial: 05010100 to 10111176); Model Catalog: 0001000311 (Lot serial: 05010100 to 10111779); Model Catalog: 01000011 (Lot serial: 02100101 to 06020501)