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 has confirmed the calibration criteria tables are missing from the s-cal calibrator kit instructions for use (ifu). the ifu refers the customers to the product manuals and/or online help. the product manual for the act 8/10 does not contain the calibration criteria table.
Model Catalog: 179310 (Lot serial: ALL); Model Catalog: 624519 (Lot serial: RELEASED AFTER DECEMBER 2009); Model Catalog: 179310 (Lot serial: RELEASED AFTER DECEMBER 2009); Model Catalog: 624519 (Lot serial: ALL)