Recall of Device Recall ARCHITECT STAT TroponinI Reagent

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Laboratories MPG.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
    Class 1
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Troponin-I Reagent - Product Code MMI
  • Reason
    False negative results : the analytical sensitivity claim of less than or equal to 0.01 ng/ml (ug/l) might not be met for all lots of architect stat troponin-i reagents, thus false negative results may occur with negative results less than 0.1 ng/ml.
  • Action
    Abbott sent a Product Correction letter on 3/8/07 to all Troponin-I customers who received reagent lots in the last 12 months. The letters informed the accounts that the analytical sensitivity claim of


  • Model / Serial
    Lot numbers 11455C006, 11605UN06, 12072UN06, 14818UN06, 13037UN06, 12990UN06, 12982UN06, 11456C006, 11609UN06, 14817UN06, 14339UN06, 13590UN06, 12986UN06, 14350UN06, 13122UN06, 12978UN06, 11370C006
  • Product Classification
  • Device Class
  • Implanted device?
  • 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


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