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 received an increased number of complaints related to the hemoglobin (hgb) parameter on the coulter lh 500 and coulter hmx hematology systems. the investigation has revealed that the issues may be related to variability in a component of the coulter isoton iii and coulter lh series diluent reagents which in turn may lead to a film coating the inside of the white blood cell (wbc) bath where hgb is measured. the use of the affected diluent lots may result in symptoms including: 1. failures in hgb background at startup or during a background cycle. 2. increases in incomplete computations (...) for hgb.
Model Catalog: 8547194 (Lot serial: M405237 through M503553); Model Catalog: 8547194 (Lot serial: 510409F through 510657F); Model Catalog: 8546733 (Lot serial: 50793F through 50818F)