Device Recall ADVIA Centaur Systems TnlUltra assay

  • 모델명 / 제조번호(시리얼번호)
    Kit Lots Ending In: 078, 079, 082, 083, 084
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including PR and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY, and the countries of Canada, Mexico, Argentina, Austria, Australia. Bahrain, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, French Polynesia, Great Britain, Greece, Guadeloupe, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Latvia, Lebanon, Libya, Macedonia, Malaysia, ,Malta, Martinique, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Republic of Korea, Romania, Russian Federation, Serbia, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sri Lanka, South Africa, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Uruguay, and Vietnam.
  • 제품 설명
    ADVIA Centaur¿ Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 10317790
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Siemens Healthcare Diagnostics, Inc, 333 Coney St, East Walpole MA 02032-1516
  • 제조사 모회사 (2017)
  • Source
    USFDA