Device Recall Folate Low and High Controls

  • Model / Serial
    List 9C13-10, lots 95523M200, 08899M100
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    There was no U.S. distribution. The products were shipped internationally through Abbott affiliates in Canada, Germany, Singapore, Hong Kong, Australia, Brazil, New Zealand, Columbia, Chile, Uruguay, United Kingdom, Venezuela, Dominican Republic, Argentina and Curacao.
  • Product Description
    Folate Low and High Controls, list 9C13-10; the pack contains 8 - 2 mL bottles( 4 for each level), Low Control L 2.5 ng/mL and High Control H 15.0 ng/mL; 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