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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Immunocap allergen fx20 food contains a mix of f4 (wheat) f5 (rye) f6 (barley) f9 (rice). due to a production nonconformity the above mentioned lots of immunocap allergen fx20 food contain traces of oat (f7) allergen. the described nonconformity could cause false positive test results with regard to sensitization to fx20 allergens for samples that are positive for oat allergen and negative for wheat rye barley and rice allergens. however this is an unlikely event because of the extensive cross-reactivity between different cereal allergens and the low probability of monosensitization to oat allergen in patients. therefore it is unlikely that presence of oat allergen in immunocap allergen fx20 should result in incorrect test results for patient samples.