Device Recall VIDAS Estradiol II (E2 II)

  • Model / Serial
    Lots 1005081700, 1005172850 & 1005359170
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including AZ, CA, CO, FL, GA, IN, IA, LA, MI, MS, NY, NC, OH, OK, OR, PA, TX, WA
  • Product Description
    VIDAS Estradiol II, Ref 30431-01, 60 tests || The VIDAS Estradiol II (E2 II) assay is intended for use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantitative enzyme-linked fluorescent immunoassay (ELFA) to the determination of total estradiol concentration in human serum or plasma (heparin).
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    BioMerieux SA, Chemin De L'Orme, Marcy L'Etoile France
  • Manufacturer Parent Company (2017)
  • Source
    USFDA