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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Siemens healthcare diagnostics has received complaints regarding panel degradation with a portion of the microscan neg breakpoint combo 34 (nbp34) panel lot 2014-05-28. siemens investigation has confirmed that a portion of the panel lot was packaged with compromised foil pouches (punctures in the foil). the substrates on the panels packaged with the compromised foil may deteriorate overtime due to exposure to additional moisture and heat.