Events

Recall of Device Recall ARCHITECT c8000 System

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
    34266
  • Event Risk Class
    Class 3
  • Event Number
    Z-0398-06
  • Event Initiated Date
    2005-12-08
  • Event Date Posted
    2006-01-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-09-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43391
  • 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
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
  • Reason
    System software assigns a calibrator default volume of 2.0ul when field is left empty by operator at time assay parameters set. patient results could be affected if the volume required is not 2.0 ul.
  • Action
    Firm initiated recall to all consignees via letter dated 12/08/05.

Device

Device Recall ARCHITECT c8000 System
  • Model / Serial
    All lots/serial numbers.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide. Product distributed nationwide to direct accounts (including gov''t accounts) in: AL, AZ, CA, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MO, MN, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and WY. Foreign distribution to the following countries: Argentina, Australia, Bermuda, Brazil, Canada, Chile, Columbia, Ecuador, El Salvador, Germany, Grand Cayman, Guatemala, Hong Kong, Jamaica, Mexico, New Zealand, Panama, Puerto Rico, Singapore, Thailand, Trinidad, Uruquay and Venezuela.
  • Product Description
    ARCHITECT c8000 System Software, Version 2.11, Product List/Model #5F48-12, distributed by Abbot 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