Device Recall Access 2 Immunoassay System

  • 모델명 / 제조번호(시리얼번호)
    Serial/Lot Numbers: 570005-570043, 570047-570049, 570051-570061, 570066-570071, 570073-570091, 570093-570123, 570125, 570126, 570128, 570131-570153, 570156-570203, 570205-570241, 570244-570248, 570250-570252 and 512684
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US, Argentina, Canada, Chile, China, Columbia, Costa Rica, France, Georgia, Germany, Ghana, Greece, Hong Kong, India, Italy, Japan, Kazakhstan, Mexico, Morocco, Myanmar, Nepal, Philippines, Poland, Russia, Rwanda, Saudi Arabia, Slovakia, South Africa, South Korea, Thailand, Turkey, United Kingdom, and Vietnam.
  • 제품 설명
    Access 2 Immunoassay System, Catalog Number 81600N. || In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 4 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Serial No. 511527 - 511678; 511681 - 512212
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Affected geographies: Algeria, Austria, Australia, Bangladesh, Bulgaria, Brazil, Canada, China, Costa Rica, Cyprus, Colombia, Czech Republic, El Salvador, France, Germany, Ghana, Greece, Guatemala, India, Indonesia, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Lithuania, Malawi, Mexico, Morocco, Myanmar, Nepal, Oman, Panama, Philippines, Pakistan, Paraguay, Poland, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Serbia, South Africa, South Korea, Spain, Switzerland, Tunisia, Turkey, United Kingdom, United States, Vietnam, Zimbabwe
  • 제품 설명
    Access 2 Immunoassay Systems, Part No. 81600N || Product Usage: || The Access 2 and UniCel DxI Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Serial No. 501012,501110,501190,501224,501294,501371,501394,501403,501440, 501443,501490,501501,501673,501681,501693,501861,501920,501926, 501936,501970,502165,502196,502319,502331,502332,502368,502458, 502475,502506,502543,502549,502556,502574,502640,502647,502651, 502791,502843,502848,503153,503279,503313,503354,503384,503392, 503424,503543,503627,503678,504046,504071,504072,504092,504112, 504195,504322,504365,504370,504756,504767,504902,505042,505195, 505251,505254,505644,505795,505840,505947,506002,506026,506108, 506119,506153,506187,506371,506406,506560,506586,506664,506708, 506766,506786,506837,506846,507039,507120,507161,507162,507214, 507229,507248,507282,507353,507397,507480,507511,507604,507619, 507842,507929,508019,508096,508179,508227,508313,508334,508412, 508478,508509,508516,508767,509051,509087,509113,509164,509253, 509297,509632,509837,510049,511042,511047,511180,511383,700024, 800321,800341,800443,800608,800611,800650,800849
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Affected geographies: Algeria, Austria, Australia, Bangladesh, Bulgaria, Brazil, Canada, China, Costa Rica, Cyprus, Colombia, Czech Republic, El Salvador, France, Germany, Ghana, Greece, Guatemala, India, Indonesia, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Lithuania, Malawi, Mexico, Morocco, Myanmar, Nepal, Oman, Panama, Philippines, Pakistan, Paraguay, Poland, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Serbia, South Africa, South Korea, Spain, Switzerland, Tunisia, Turkey, United Kingdom, United States, Vietnam, Zimbabwe
  • 제품 설명
    Access 2 assay Immunoassay System, Remanufactured, Part No. 386220 || Product Usage: || The Access 2 and UniCel DxI Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Serial/Lot Numbers: 507114, 503299 and 508111
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US, Argentina, Canada, Chile, China, Columbia, Costa Rica, France, Georgia, Germany, Ghana, Greece, Hong Kong, India, Italy, Japan, Kazakhstan, Mexico, Morocco, Myanmar, Nepal, Philippines, Poland, Russia, Rwanda, Saudi Arabia, Slovakia, South Africa, South Korea, Thailand, Turkey, United Kingdom, and Vietnam.
  • 제품 설명
    Access 2 Immunoassay System, Remanufactured, Catalog Number 386220. || In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Serial/Lot Numbers: 801060 and 801061
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US, Argentina, Canada, Chile, China, Columbia, Costa Rica, France, Georgia, Germany, Ghana, Greece, Hong Kong, India, Italy, Japan, Kazakhstan, Mexico, Morocco, Myanmar, Nepal, Philippines, Poland, Russia, Rwanda, Saudi Arabia, Slovakia, South Africa, South Korea, Thailand, Turkey, United Kingdom, and Vietnam.
  • 제품 설명
    UniCel DxC 600i SYNCHRON Access Clinical Systems; A25656, A25638. || In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
  • Manufacturer