Devices

Device Recall ARCHITECT STAT TroponinI Reagent

  • Model / Serial
    Lot numbers 11455C006, 11605UN06, 12072UN06, 14818UN06, 13037UN06, 12990UN06, 12982UN06, 11456C006, 11609UN06, 14817UN06, 14339UN06, 13590UN06, 12986UN06, 14350UN06, 13122UN06, 12978UN06, 11370C006
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide: USA including Puerto Rico, and internationally to Canada, Brazil, Germany, Japan, Taiwan, Hong Kong, Thailand, South Korea, Australia, New Zealand, Mexico, Colombia, Chile, Argentina and Trindad & Tobago.
  • Product Description
    ARCHITECT STAT Troponin-I Reagent; list numbers 2K41-20 (400 test kit), 2K41-25 (100 test kit) and 2K41-30 (2000 test kit); each kit contains bottles of microparticles, conjugate and assay diluent; 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

One device with a similar name

Learn more about the data here

Device Recall ARCHITECT STAT TroponinI Reagent Kit
  • Model / Serial
    list 2K41-20, lot 95567G005, exp 6-30-2006
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and internationally to Canada, Australia, Germany and Taiwan
  • Product Description
    ARCHITECT STAT Troponin-I Reagent Kit, list 2K41-20; each 400 test kit contains 4 bottles each of microparticles, conjugate and assay diluent; Abbott Laboratories, Abbott Park, IL 60064
  • Manufacturer
    Abbott Laboratories MPG