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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This recall was initiated because ortho was made aware of new information regarding the potential for n-acetylcysteine (nac) to interfere with specific vitros chemistry products slide assays (glu lac trig and uric). patients who were administered nac could potentially have biased sample results.