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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Siemens healthcare diagnostics has become aware of a problem with the substrate component. the vial containing the substrate is defective and the cap does not fit securely allowing substrate reagent to leak out of the vial if it is not stored upright at all times. the leakage could present itself as an empty or underfilled substrate reagent. no evidence shows taht this problem will impact the quality of any test results produced from this reagent. this issue has been investigated and confirmed by them manufacturer.