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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Due to a software issue on the cobas 8000 analyzer a mismatch between the reagent probe positioning on the cobas c 701 and c 702 analyzers and the aspirated reagent volumes may occur under certain high throughput conditions. this may lead to partial air pipetting at the end of the cobas c pack large possibly affecting patient sample and control recovery.