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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Ortho-clinical diagnostics inc. (ocd) has confirmed instances where the vitros system allowed urine samples for assays that required acidified pretreatment to be metered from the same sample container as assays that required no pretreatment when the sample was programmed. this has been attributed to a software anomaly. depending upon the assay urine samples either need to be acidified alkalized or require no pretreatment. the anomaly occurs when manually programming urine samples or using a downloaded sample program from a laboratory information system (lis) and the sample program contains assays requiring sample pretreatment and assays requiring no sample pretreatment. if this anomaly occurs it is possible for vitros 51 4600 or 5600 systems to process urine samples without the proper pretreatment potentially leading to biased patient results.