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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Siemens healthcare diagnostics has determined that dimension vista mass ckmb isoenzyme calibrator(mmb cal) shows drift during routine stability monitoring that exceeds the acceptance criteria for drift over the shelf life of this product (12 months). siemens has observed drift from 3% to 12% at mmb concentrations across the assay range. depending on quality control limits this drift may not have been detected. due to the drift siemens is revising the expiration date of this product (to 6 months). siemens is issuing an urgent field safety notice letter for the aforementioned lots of dimension vista mmb cal.