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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During qc testing the other equipment manufacturer (oem) discovered precipitates in some of the r2 reagent casettes of the abx pentra calcium cp (a11a01633) from the lot #: 014664503. the initial functional tests conducted by the oem indicate there is currently no effect on patient results. however in a previous lot the oem did identify aberrant results related to the presence of these precipitates. therefore with time there may be an increase in the quantity of precipitates and by extension a risk of incorrect patient results being reported.