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 that for lot numbers m908398 and m911529 of immager immunochemistry systems rheumatoid factor reagent known negative results are being reported as slightly positive (between 20 and 30 iu/ml usually). when tested on other methods or with other lots most of these slightly positive samples read < 20 iu/ml or negative. per the cis 95% of normal healthy individuals who live in southern california should have results less than 20 iu/ml. customers utilizing these lots are reporting patient results in more than 5% of their samples with results greater than 20 iu/ml.