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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The advia centaur assays listed above show changes in patient samples and quality control values when the ambient temperature of the room or laboratory shifts between 18 c - 30 c where the advia centaur system is installed. these assays are not meeting the specifications within the operating temperature range which is 18 c - 30 c. this effect occurs on either the advia centaur advia centaur xp and/or advia centaur cp systems depending on the assay and the system.
Model Catalog: 06891541 (Lot serial: ); Model Catalog: 02816138 (Lot serial: ); Model Catalog: 06367974 (Lot serial: ALL LOTS FOR ALL DEVICES); Model Catalog: 06891541 (Lot serial: ALL LOTS FOR ALL DEVICES); Model Catalog: 02419937 (Lot serial: ); Model Catalog: 03896216 (Lot serial: ); Model Catalog: 03204829 (Lot serial: ); Model Catalog: 01157807 (Lot serial: ); Model Catalog: 02816634 (Lot serial: ); Model Catalog: 06489701 (Lot serial: ); Model Catalog: 04612750 (Lot serial: ); Model Catalog: 03481938 (Lot serial: ); Model Catalog: 10491379 (Lot serial: ); Model Catalog: 10491244 (Lot serial: ); Model Catalog: 03009619 (Lot serial: ); Model Catalog: 08838753 (Lot serial: ); Model Catalog: 06367974 (Lot serial: ); Model Catalog: 09046419 (Lot serial: ); Model Catalog: 08861968 (Lot serial: ); Model Catalog: 10378883 (Lot serial: )