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 au680 and au5800 clinical chemistry analyzers are not fully compliant with the applicable emc standard (electromagnetic distrubance characteristics cispr 11/group 1 class a). the investigation revealed that a previous design change made to the cooling module resulted in the noise level of the new cooling module exceeding the emc standard limit.
Model Catalog: AU680 (Lot serial: 2013022088 to 2014012894); Model Catalog: AU5840 (Lot serial: 2013020679 to 2014121891); Model Catalog: AU5830 (Lot serial: 2013020679 to 2014121891); Model Catalog: AU5820 (Lot serial: 2013020679 to 2014121891); Model Catalog: AU5810 (Lot serial: 2013020679 to 2014121891)