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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Beckman coulter inc. identified the following issue with the above listed products: 1. the dilution recovery (linearity) data presented in the access testosterone instructions for use (ifu) does not represent the current product performance. 2. in a recent study thirty-four (34) male serum samples with testosterone values from 4 to 10ng/ml were diluted 1/2 in access testosterone calibrator s0. the neat and diluted samples were then measured using the access testosterone assay. the calculated mean recover was 110% (range = 95 to 137%).