Device Recall Access Immunoassay Systems Unconjugated Estriol

  • Model / Serial
    Lot # 913348
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) including the states of CA, CT, MA, NC, NM and TX and the country of Canada.
  • Product Description
    Access¿ Immunoassay Systems || UNCONJUGATED ESTRIOL || Part # 33570 || The Access Unconjugated Estriol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of unconjugated estriol levels in human serum using the Access Immunoassay Systems.
  • Manufacturer
  • 1 Event

Manufacturer

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