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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Beckman coulter has confirmed the following issues can be encountered when generating organism identifications in the microscan labpro information manager system from dried overnight gram negative panels processed on microscan autoscan-4 systems or read manually and entered into the labpro system. the use of dried overnight gram negative panels and the labpro software system on the walkaway system is not affected. some glucose non-fermenting organisms may display a color change (shade of yellow) in the glu suc and sor at 48 hours. when this occurs: - labpro software incorrectly allows the operator to manually edit the carbohydrate substrates (specifically glu suc and sor) when manually reading dried overnight gram negative (conventional) panels with an id hold status. - labpro software incorrectly overwrites the previously stored carbohydrate substrate results (specifically glu suc and sor) when reading dried gram negative overnight (conventional) panels which have an id hold status on the autoscan-4 system. - labpro software then incorrectly uses the fermenter identification substrates to calculate the biotype which may cause non-fermenters such as an acinetobacter species to be incorrectly identified as fermenters for example a shigella species.
Model Catalog: B1018-524 (Lot serial: Version 1.0 to Version 4.11); Model Catalog: 10361216 (Lot serial: Version 1.0 to Version 4.11); Model Catalog: 9800-3885 (Lot serial: Version 1.0 to Version 4.11); Model Catalog: 9800-3867 (Lot serial: Version 1.0 to Version 4.11); Model Catalog: 9800-3859 (Lot serial: Version 1.0 to Version 4.11); Model Catalog: 9800-3819 (Lot serial: Version 1.0 to Version 4.11); Model Catalog: 9800-3789 (Lot serial: Version 1.0 to Version 4.11); Model Catalog: 9800-3771 (Lot serial: Version 1.0 to Version 4.11); Model Catalog: 9800-3583 (Lot serial: Version 1.0 to Version 4.11); Model Catalog: 9800-3563 (Lot serial: Version 1.0 to Version 4.11); Model Catalog: 9800-3554 (Lot serial: Version 1.0 to Version 4.11); Model Catalog: 10807571 (Lot serial: Version 1.0 to Version 4.11); Model Catalog: 10638825 (Lot serial: Version 1.0 to Version 4.11); Model Catalog: 10638824 (Lot serial: Version 1.0 to Version 4.11); Model Catalog: 10638823 (Lot serial: Version 1.0 to Version 4.11); Model Ca