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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A potential for falsely low igm results obtained with serum samples when using the affected lots of n latex igm. for the assessment of intrathecal synthesis of igm with n latex igm results on cerebrospinal fluid (csf) and serum samples may be obtained from one calibration curve. if an igm quotient (igm_csf/igm_serum) is calculated using a falsely low serum result and if the result is transferred into a 'reiber diagram' this quotient will be too high and may result in an overestimation of an intrathecal igm synthesis.