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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Due to a transcription error in the clinitek novus software there is a potential for protein to creatinine (p:c) ratios of > 300 mg/g to be reported higher than expected. in particular: 1. a p:c ratio of 300 mg/g may be reported as 500 mg/g. 2. a p:c ratio of 500 mg/g may be reported as >1500 mg/g. this error can potentially occur when a clinitek novus pro12 urinalysis cassette is used on the clinitek novus analyzer. p:c ratios reported as normal or 300 mg/g are not affected.
Model Catalog: 10844557 (Lot serial: All lots); Model Catalog: 10697937 (Lot serial: All lots); Model Catalog: 10844545 (Lot serial: All lots); Model Catalog: 10494134 (Lot serial: All lots)