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 is conducting a correction for the immulite 2000/immulite 2000 xpi analyzer connected to a versacell system. there is a potential for incorrect results to be reported from processing of a sample tube if certain conditions occur on the immulite 2000/immulite 2000 xpi analyzer connected to a versacell system. this issue can only occur with versacell systems that are connected to immulite 2000/immulite 2000 xpi systems. this issue does not affect any other analyzer that interfaces with the versacell system. not every instance of a dropped tube will lead to incorrect results.
Model Catalog: 030002-33 (Lot serial: all connected to VersaCell); Model Catalog: 10373214 (Lot serial: all connected to VersaCell); Model Catalog: 030002-13 (Lot serial: all connected to VersaCell)