Device Recall Dimension Vista(R) Gentamicin (GENT) Flex(R) reagent cartridge, K4012

  • 모델명 / 제조번호(시리얼번호)
    All Lots
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
  • 제품 설명
    Dimension Vista(R) Gentamicin (GENT) Flex(R) reagent cartridge, K4012 || This method is an in vitro diagnostic test for the quantitative measurement of gentamicin, an aminoglycoside antibiotic, in human serum and plasma on the Dimension Vista System. Gentamicin measurements may be used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Siemens Healthcare Diagnostics, Inc., 500 GBC Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • 제조사 모회사 (2017)
  • Source
    USFDA