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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The currently available knowledgebase vitek ms (ruo) version 2.0 is known to have lower performance for the nine (9) mycobacteria species listed in the knowledgebase user manual supplement. additionally an internal study determined that in rare circumstances the current mycobacteria protocol might not completely inactivate multi drug resistant (mdr) m. tuberculosis when using 30/70 tfa/etoh (trifluoroacetic acid/ethanol).
Model Catalog: 410710 (Lot serial: N/A); Model Catalog: 410895 (Lot serial: N/A); Model Catalog: 410895 (Lot serial: VERSION 2.0); Model Catalog: 410710 (Lot serial: VERSION 2.0)