Device Recall ETIABAUK PLUS

  • Model / Serial
    lot numbers 0650270A and 0650270A/1.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including states of: AL, AR, CA, CT, DE, DC, FL, GA, IL, IA, KY, LA, MD, MA, MI, MN, MO, NH, NJ, NM, NY, NC, ND, OH, OK OR, PA, TX, VT, VA, WA,and WI; and country of: SOUTH KOREA.
  • Product Description
    ETI-AB-AUK PLUS kits,REF P001931, DiaSorin S.p.A., 13040 Saluggia (VC), Italy, Distributed by: DiaSorin Inc., 1951 Northwestern Avenue, P.O. Box 285, Stillwater, MN 55082-0285 || In vitro enzyme immunoassay (EIA) intended for use in the qualitative detection of antibodies to hepatitis B surface antigen (anti-HBs) in human serum or plasma.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Diasorin Inc., 1951 Northwestern Ave S, Stillwater MN 55082-7536
  • Manufacturer Parent Company (2017)
  • Source
    USFDA