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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Possible condition in a limited of abl80 flex analyzers configured either flex or basic software which can cause the analyzer to report outside the published performance specifications for ph pco2 cna+ck+ cca2+ and ccl-. this condition can occur without indication to the user.
Model Catalog: 393-839 (Lot serial: 304157); Model Catalog: 393-839 (Lot serial: 304162 through to 305409); Model Catalog: 903-227 (Lot serial: 304160); Model Catalog: 393-839 (Lot serial: 304160); Model Catalog: 903-227 (Lot serial: 304157); Model Catalog: 393-839 (Lot serial: Signal Data Board >May 2011); Model Catalog: 903-227 (Lot serial: Signal Data Board >May 2011); Model Catalog: 903-227 (Lot serial: 304162 through to 305409)