Device Recall Dimension Vista(R) MG Flex(R) Reagent Cartridge

  • 모델명 / 제조번호(시리얼번호)
    Lot numbers 11263AC, 11286AB, 11306BA, 11332AB, 11332AC and 12010AB.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including Puerto Rico and within the US to Washington, DC and the following States: AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico.
  • 제품 설명
    Dimension Vista(R) MG Flex(R) Reagent Cartridge || The Dimension Vista(R) MG method is an in vitro diagnostic test for the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista(R) System
  • 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