Device Recall Unicel DxC 600i SYNCHRON Access Clinical Systems

  • Model / Serial
    Serial No. (Part No. A25637) 800999,801019  Serial No. (Part No. A25638)800995,800996,800997,800998,801000,801001,801002,801003,801004, 801005,801006,801007,801008,801009,801010,801011,801012,801013, 801014,801015,801016,801017,801018,801020,801021,801022,801023, 801024,801025,801026,801027
  • Product Classification
  • Device Class
    1
  • Implanted device?
    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
  • Product Description
    UniCel DxC 600i SYNCHRON Access Clinical System, Part No. A25637, A25638 || 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

Manufacturer

  • Manufacturer Address
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Manufacturer Parent Company (2017)
  • Source
    USFDA