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 diagnostic (ocd) has received complaints of the inability to calibrate the vitros? chemistry products hpt reagent. ocd has also received reports of an increase in u91-274 condition codes. although all affected lots met all release testing specifications prior to distribution an ocd investigation has confirmed an increased occurrence of condition codes and calibration failures when using these lots over a period of time. ocd testing has found that as the reagent ages a potential for biased results exists if you are able to obtain a valid calibration.