Device Recall VITEK 2 Gram Negative test kit containing colistin (cs01n)

  • 모델명 / 제조번호(시리얼번호)
    REF # (Description): 418114 (AST-GN94), 22258 (AST-N102), 412605 (AST-N194), 412921 (AST-N199), 412862 (AST-N201), 412863 (AST-N202), 412924 (AST-N205), 412918 (AST-N210), 413061 (AST-N212), 413083 (AST-N222), 413112 (AST-N225), 413171 (AST-N236), 413172 (AST-N237), 413204 (AST-N239), 413205 (AST-N240), 413391 (AST-N242), 413394 (AST-N245), 413397 (AST-N248), 413572 (AST-N249), 413722 (AST-N253), 413724 (AST-N255), 413725 (AST-N256), 413753 (AST-N261), 414164 (AST-N272), 414286 (AST-N276), 414492 (AST-N279), 414531 (AST-N280), 414532 (AST-N281), 414972 (AST-N288), 415063 (AST-N292), 415369 (AST-N293), 415433 (AST-N295), 416005 (AST-N299), 416241 (AST-N300), 416590 (AST-N303), 416913 (AST-N308), 416914 (AST-N309), 417426 (AST-N315), 417952 (AST-N318), 418204 (AST-N320), 418489 (AST-N322), 418513 (AST-N235), 418514 (AST-N326), 418630 (AST-N328), 418631 (AST-N329), 418675 (AST-N331), 418676 (AST-N332), 418985 (AST-N335), 419077 (AST-N338), 419341 (AST-N339), 420063 (AST-N343), 420440 (AST-N344), 420867 (AST-N347), 420856 (AST-N348), 421258 (AST-N352), 421297 (AST-N353), 421350 (AST-N354), 421351 (AST-N355, 421451 (AST-N357), 421441 (AST-N358), 421583 (AST-N360), 421584 (AST-N361), 421585 (AST-N362), 421692 (AST-363), 421693 (AST-N364), 421830 (AST-N365), 421853 (AST-N366), 421854 (AST-N367), 421855 (AST-N368), 410025 (AST-XN01), 413230 (AST-XN05)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Domestic: NC. Foreign: Argentina, Austria, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, France, Germany, Guatemala, Hong Kong, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Netherlands Antilles, Nicaragua, Panama, Paraguay, Peru, Philippines, Poland, Singapore, South Africa, South Korea, Spain, Thailand, Turkey, United Kingdom, Uruguay, Venezuela, & Vietnam.
  • 제품 설명
    VITEK 2 Gram Negative test kits containing colistin (cs01n)
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Biomerieux Inc, 595 Anglum Rd, Hazelwood MO 63042-2320
  • 제조사 모회사 (2017)
  • Source
    USFDA