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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Access afp qc kits contain three levels of control material identified as qc1 qc2 and qc3. beckman coulter has confirmed that vials of qc1 in certain kit lots contain microbial contamination.