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.
데이터 추가 비고
원인
The aqc cartridge can be difficult to remove from the analyzer system and will occasionally post a d33:2 valve error and fail to eject from the instrument. the error is generated only during a failed ejection of the aqc cartridge. the issue appears to coincide with the recent introduction of the new return spring design for the aqc cartridge.
Model Catalog: 120241 (Lot serial: 1350036305); Model Catalog: 10310323 (Lot serial: 1350036305); Model Catalog: 05293926 (Lot serial: SERIAL NUMBERS 1335866035 TO); Model Catalog: 120241 (Lot serial: SERIAL NUMBERS 1335866035 TO); Model Catalog: 10310323 (Lot serial: SERIAL NUMBERS 1335866035 TO); Model Catalog: 05293926 (Lot serial: 1350036305)