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 customer complaints about qc recovery for parameter "free ig/l-chain type lambda" using several n latex fls lambda reagent / n flc control sl1 and n flc control sl2 combination on bn prospec system. controls were measured outside the upper limit of the confidence range. manufacturer has confirmed a higher than than expected rate of invalid runs.