Device Recall SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 38050 and 38060.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including states of AK, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, MO, NC, ND, NH, NM, NY, OR, PA, SC, SD, TN, TX, VA, WA and WY.
  • 제품 설명
    Quantimetrix Synovialscopics Synovial Fluid Control. || Synovialscopics is a plastic bottle Synovial fluid cell count control. It is a control for monitoring total cell counts in patient Synovial fluid samples performed manually using a hemocytometer. It is also an aid for identifying the crystals which may indicate a pathological condition present in the Synovial fluid. This control is used as a third party control to confirm proper functioning of the analysis by microscopic evaluation.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Quantimetrix Corporation, 2005 Manhattan Beach Blvd, Redondo Beach CA 90278-1205
  • 제조사 모회사 (2017)
  • Source
    USFDA