Events

Recall of Device Recall ARCHITECT i2000

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

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
    Recall
  • Event ID
    36996
  • Event Risk Class
    Class 2
  • Event Number
    Z-0415-2007
  • Event Initiated Date
    2006-12-12
  • Event Date Posted
    2007-02-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-09-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49733
  • 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
    in vitro diagnostic - Product Code JJE
  • Reason
    The re-designed architect temperature controller board has been identified as being susceptible to electromagnetic interference (emi) in the laboratory. this can cause a board reset condition, stopping temperature control function of the board. situation does not stop analyzer operation and does not generate an error condition alerting operator when condition occurs.
  • Action
    Firm contacted consignees by telephone and fax with instructions to verify proper functioning of the Temperature Controller Board starting December 13, 2006.

Device

Device Recall ARCHITECT i2000
  • Model / Serial
    Serial numbers: 1202790, 1202804, 1202805, 1202806, 1202807, 1202808, 1202809, 1202810, 1202811, 1202812, 1202813, 1202814, 1202815, 1202816, 1202817, 1202818, 1202819, 1202820, 1202821, 1202822, 1202823, 1202824, 1202825, 1202826, 1202827, 1202828, 1202829, 1202830, 1202831, 1202832, 1202833, 1202834, 1202835, 1202836, 1202837, 1202838, 1202839, 1202840, 1202841, 1202842, 1202843, 1202844, 1202845, 1202846, 1202847, 1202848, 1202849, 1202850, 1202851, 1202852, 1202853, 1202854, 1202855, 1202856, 1202857, 1202858, 1202859.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Argentina, Australia, Brazil, Canada, Chile, Columbia, Dominican Republic, Germany, Hong Kong, Jamaica, Japan, Korea, Mexico, New Zealand, Peru, Puerto Rico, Singapore, Taiwan, Thailand, Trinidad, Tobago, Uruguay, and Venezuela.
  • Product Description
    ARCHITECT i2000 Processing Module, for in vitro diagnostics, List Number 08C89-01; Temperature Controller Board Part #78560-109; distributed by Abbott Laboratories, Irving, TX.
  • Manufacturer
    Abbott Laboratories, Inc

Manufacturer

Abbott Laboratories, Inc
  • Manufacturer Address
    Abbott Laboratories, Inc, 1921 Hurd Drive, PO Box 152020, Irving TX 75038
  • Source
    USFDA