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 identified an anomaly with vitros 51 fs system version 2.6.1 software and below and vitros 5600 integrated system software version 2.0 and below. for the ease of workflow vitros analyzers allow multiple lots of the same reagent to be on board the system at the same time. the system automatically switches to the next lot when the "in use" lot is depleted or when the operator manually changes the lot that is in use. in this issue following a successful calibration of the new gens of vitros vanc [vancomycin] reagent (gen 21 and up) or vitros valp [valproic acid] reagent ( gen 16 and up) the system can unexpectedly switch and use the previous (old) lot on board the system to process post-calibration quality control samples. if the operator doesn't notice the lot switch condition code (pv2-097) posted on their screen the new calibration may not be verified by the proper quality control (qc) verification. based on that biased results could potentially occur from a calibration that is suboptimal.