Device Recall Access 2 Immunoassay System.

  • Modèle / numéro de série
    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
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    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
  • Description du dispositif
    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
  • 1 Event

Fabricant

  • Adresse du fabricant
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Société-mère du fabricant (2017)
  • Source
    USFDA