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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Increase in frequency of absorbance errors [e141: iod error] on patient samples with the dimension vista pche flex reagent lots: 14147bc 14160ba 14168ab and 14198ac. the [e141: iod error] flag is generated from an iod (initial optical density) test value that is less than the software coded limit of 575. the iod test calculation is used to monitor reagent delivery. reagent that does not produce the typical colour may also generate lower than normal iod test values triggering the [e141: iod error] flag. the issue does not affect every flex and not all well sets. only patient samples with values close to the upper end of the assay range will be impacted and the absorbance error [e141: iod error] flag are not reportable.