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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Potential problem with the 10-tooth (10t) and 14-tooth (14t) mixer pulley assemblies in the access family of immunoassay systems. it has been determined that in some cases pulley drive components have broken parts or have become loose mis-positioned or disconnected from their drive. when these defects occur the pulley might not turn at all or may turn at an incorrect speed resulting in inadequate mixing of the contents of the reaction vessel which can lead to erroneous test results.