Device Recall Dimension Troponin 1

  • 모델명 / 제조번호(시리얼번호)
    Device Listing Number # D056469 Lot # EB7091, EC7104, EA7125, ED7193, EA7161, EB7173, EC7229, ED7236 EA7250, ED7271, EB7315, EB7342   "
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product was distributed throughout the United States and Canada, United Arab Emirates, Argentina, Austria,Australia,Bangladesh,Belgium,Brazil,Canada Switzerland,China,Columbia,Czech Republic,Germany,Denmark,Algeria Egypt,Spain,Finland,France,Great Britain,Greece,Croatia,Indonesia,Ireland India,Italy,Japan,Canary Islands,Republic of Korea,Kuwait,Lebanon,Latvia Macedonia,Netherlands,Norway,New Zealand,Philippines,Poland,Portugal Qatar,Saudi Arabia,Slovenia,Slovakia,Turkey,Taiwan,South Africa
  • 제품 설명
    Dimension Troponin 1 (TNI) Flex reagent cartridge
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • 제조사 모회사 (2017)
  • Source
    USFDA