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. has confirmed the following maintenance-related hardware issues can cause or contribute to erroneous electrolyte results on the synchron lxr20 synchron lxr20 pro and synchron lxri 725 clinical systems: 1. ratio pump wear 2. silver iodide build-up on the chloride electrode which if not removed may affect chloride performance and shorten the usable life of the electrode and 3. microbial contamination introduced into the system via the deionized water source reagent straws or other external sources. the use of incompatible bleach and saline products for the twice-weekly flow cell cleaning procedure may introduce electrolyte instability in the synchron lx20 system.