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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원인
The manufacturer has identified during internal investigation following customer injury complaints that a new mandatory cleaning procedure for sample rack trays was required to mitigate the risk of > potential user injury.
Model Catalog: 06390498001 (Lot serial: More than 100 contact manuf.); Model Catalog: 07649142001 (Lot serial: More than 100 contact manuf.); Model Catalog: 04745922001 (Lot serial: More than 100 contact manuf.); Model Catalog: 28122474001 (Lot serial: More than 100 contact manuf.); Model Catalog: 05964067001 (Lot serial: More than 100 contact manuf.); Model Catalog: 03051323001 (Lot serial: More than 100 contact manuf.); Model Catalog: 05990378001 (Lot serial: More than 100 contact manuf.); Model Catalog: 05412722001 (Lot serial: More than 100 contact manuf.); Model Catalog: 05524245001 (Lot serial: More than 100 contact manuf.); Model Catalog: 06473245001 (Lot serial: More than 100 contact manuf.); Model Catalog: 05641489001 (Lot serial: More than 100 contact manuf.); Model Catalog: 04775201001 (Lot serial: More than 100 contact manuf.); Model Catalog: 05082579001 (Lot serial: More than 100 contact manuf.); Model Catalog: 05083435001 (Lot serial: More than 100 contact manuf.); Model Catalog: 03530744001 (L
제품 설명
COBAS 6500 U601 URINALYSIS SYSTEM - URINE ANALYZE;COBAS C 513 ANALYZER;COBAS 6000 - E601;COBAS INTEGRA SYSTEM - COBAS INTEGRA 800 ANALYZER;COBAS 8000 C502 STAND ALONE CONFIGURATION;URISYS 2400 ANALYSER;COBAS 8000 E602 IMMUNOASSAY ANALYZER;COBAS 8800;COBAS