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 differences in recovery of pfb in vigil protein control using pfb reagent lots m206298 m301364 m302049compared to values obtained using previous pfb reagent lots. these control differences are due to a change in the pool of antiserum material that is used in the manufacture of the pfb reagent. thecontrol range tables included in vigil protein control lots m210051 m210052 and m210053 do not reflect pfb values obtained with pfb reagent lots m206298 m301364 and m302049.