Devices

Device Recall CA 153 Controls

  • Model / Serial
    list 9C08-10; lot number 29506M100, expiration date July 5, 2006
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including U.S.A., Puerto Rico, Canada, Mexico, Ecuador, Chile, Argentina, Brazil, Germany, Japan, SIngapore, Hong Kong, Thailand, South Korea and Australia.
  • Product Description
    CA 15-3 Controls, list 9C08-10; an In Vitro diagnostic for use with the AxSYM or IMx CA 15-3 reagents, calibrators and instruments; each kit contains 2 bottles with 115D8:DF3 reactive determinants (human) prepared in TRIS buffer with protein (bovine) stabilizers to yield the following assay values (U/ml): Control L - 35 and Control H - 150; Abbott Laboratories, Abbott Park, IL 60064
  • Manufacturer
    Abbott Laboratories MPG
  • 1 Event

Manufacturer

Abbott Laboratories MPG
  • Manufacturer Address
    Abbott Laboratories MPG, 100 Abbott Park Rd, Abbott Park IL 60064-3502
  • Source
    USFDA