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 determined through internal testing that access il-6 calibrator lot 217782 has failed to meet its stability specifications and expiration dating. access il-6 calibrator lot 217782 may generate falsely elevated patient sample and quality control results across the reportable assay range. based on internal testing the customer may experience patient sample and quality control results approximately 15% higher than the corresponding values observed in baseline testing against this calibrator lot. the issue was discovered through internal testing in april 2015. there has been no report of death or injury related to this issue.