Device Recall ARCHITECT Folate Control Kit

  • Model / Serial
    List 6C12-10, Lots 94718M200 and 04619M100
  • 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
    ARCHITECT¿ Folate Low and Medium Controls, List 6C12-10; the kit contains 2 - 8 mL vials, Low Control L 2.5 ng/mL and Medium Control M 7.0 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