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 inc. (bec) has identified that two access papp-a quality control (qc) lots (120380 122262) may generate mean values below the mean values stated on the qc cards. the average difference observed in bec's internal investigation was 11% below the stated mean. the results observed may vary based on the combination of reagent and calibrator lots in use. reduced qc could lead to repeat testing and a potential delay in reporting patient results.