Device Recall Dade(R) Actin(R) FSL Activated PTT Reagent

  • 모델명 / 제조번호(시리얼번호)
    Catalog number B4219-1J, lot numbers 537360, 537374 and 547301; catalog number B4219-1, lot numbers 537360A, 537366, 537374A, 547301A, and 547306; catalog number B4219-2J, lot numbers 534362 and 537365; and catalog number B4219-2, lot numbers 537362A and 537365A.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) including the states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY and the countries of Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Columbia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Guatemala, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Mongolia, Netherlands, Oman, Philippines, Poland, Portugal, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom and Vietnam.
  • 제품 설명
    Dade(R) Actin(R) FSL Activated PTT Reagent || Product Usage: || Liquid purified soy and rabbit brain phosphatides with plasma activator. An activated partial thromboplastin reagent with increased sensitivity to lupus-like inhibitors for use in the determination of the activated partial thromboplastin time (APTT) and related coagulation procedures.
  • 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

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 1 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Catalog numbers B4219-1 and B4219-2: lot numbers 547311, exp 3/22/2013; 547312, exp 3/22/2013 and 547316A, exp 4/28/2013.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV and Puerto Rico and the country of Canada.
  • 제품 설명
    Dade(R) Actin(R) FSL Activated PTT Reagent. || For use in the determination of the activated partial thromboplastin time (APTT).
  • Manufacturer