Device Recall AxSYM Homocysteine Reagent Pack

  • Model / Serial
    list 5F51-20, lots 01724M300, 03314HN00, 03533HN00
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Lot 01724M300 was distributed nationwide, as well as to Canada, Singapore, Tahiland, Korea, Hong Kong and China. Lots 03314HN00 and 03533HN00 were distributed by Abbott's Delkenheim, Germany subsidiary worldwide outside of the United States. These two lots were not distributed in the U.S.
  • Product Description
    AxSYM Homocysteine Reagent Pack, list 5F51-20, Produced by Axis-Shield, Oslo, Norway, for Abbott Laboratories, Abbott Park, IL 60064 USA
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Abbott Laboratories HPD/ADD/GPRD, 100/200 Abbott Park Road, Abbott Park IL 60064
  • Source
    USFDA