Events

Recall of 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
    33460
  • Event Risk Class
    Class 2
  • Event Number
    Z-0010-06
  • Event Initiated Date
    2005-09-14
  • Event Date Posted
    2005-10-06
  • 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=41910
  • 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
    Software deficiency causing potential shift in absorbance readings for test results.
  • Action
    Firm sent device correction letter to consignees on 9/14/2005.

Device

ARCHITECT c8000 System
  • Model / Serial
    All serial numbers, List number 1G06-01
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and 21 foreign countries. Foreign countries: Mexico, Guatemala, Venezuela, Colombia, Ecuador, Chile, Uruguay, Argentina, Brazil, Puerto Rico, Jamaica, San Salvador, Canada, Germany, Singapore, China, Thailand, Australia, New Zealand, Panama, and Grand Cayman
  • Product Description
    ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations.
  • Manufacturer
    Abbott Laboratories, Inc

Manufacturer

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