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 is sending an urgent field safety notice to customers to remind them that the neonatal bilirubin (nbili) parameter on the rapidpoint 405 rapidpoint 500 rapidlab 1245 and rapidpoint 1265 analyzers may have increased variability when the nbili concentration is >12 mg/dl (205 micro mol/l) and the thb concentration exceeds the upper reportable range of >25 g/dl (15.5mmol/l). when this occurs the analyzer may report a nbili result that is higher or lower than expected.
Model Catalog: RAPIDPOINT 500 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: RAPIDPOINT 405 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 1265 (Lot serial: ALL SERIAL NUMBERS)