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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Manufacturer received customer complaints for falsely elevated advia chemistry lipase results as a result of carryover from cholesterol_c dldl and triglycerides reagents. manufacturer internal investigation confirmed that current contamination avoidance settings do not prevent carryover resulting in high lipase outlier results. the results generated when this issue occurs are falsely elevated for a normal range lipase sample. customers have reported approximately a 25% positive bias while approximately a 12% positive bias was observed in-house. the issue may or may not be detected by quality controls depending on where a carryover incident occurs. if carryover occurs during qc analysis it will impact the qc result. if it does not occur during a qc analysis then the qc result will not be affected.