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.
데이터 추가 비고
원인
Ocd has revised the storage instructions for vitros immunodiagnostic products ckmb calibrators. internal testing demonstrated that opened reconstituted vitros ckmb calibrators stored at -20 c generated invalid calibrations that were detected by positively biased quality control results. as a result you must discontinue storage of opened-reconstituted vials of vitros ckmb calibrators frozen at -20 c. refrigerated storage at 2-8 c remains acceptable. the revised ifu will be posted online shortly. in the meantime the customer communication asks that customers post this communication by each vitros system that utilized vitros ckmb calibrators or with their user documentation records.