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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Ocd has received customer complaints of a downward drift/shift in quality control results or low quality control results when using vitros chemistry products cocm reagent. this drift/shift will likely be observed within approximately 3-14 days of calibration. patient results may be affected in the same manner. our investigation has shown that recalibration will be initially effective in resolving the issue but that increased calibration frequency may no longer be effective over time. ocd internal testing has confirmed that this issue occurs will all lots of vitros cocm reagent that are within expiration dating. as a result customers are being asked to discontinue using and discard all vitros cocm reagent remaining in their inventory.