Events

Recall of Device Recall ARCHITECT c8000

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
    27731
  • Event Risk Class
    Class 2
  • Event Number
    Z-0263-04
  • Event Initiated Date
    2003-11-17
  • Event Date Posted
    2003-12-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-10-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30431
  • 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
    Calculator/Data Processing Module, For Clinical Use - Product Code JQP
  • Reason
    Sample identification (sid) numbers of a bar coded sample may be truncated, or shortened, after being scanned by the bar code reader (e.G. an actual sid of 123456 is shortened to 1234).
  • Action
    The firm plans to distribute a Product Information Letter and an updated ARCHITECT i System Operations Manufal Addendum to all US ARCHITECT customers. An electronic version of these documents was sent to all Abbott affilities worldwide for distribution to their ARCHITECT customers.

Device

Device Recall ARCHITECT c8000
  • Model / Serial
    List Number 1G06-01, all serial numbers
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Mexico, Puerto Rico, Japan, Taiwan, Australia, Colombia, Cananda, Hong Kong, New Zealand, Netherlands, Singapore, Germany, Grand Cayman, Korea, Chile, Thailand, TX, PA, SC, CA, IN.
  • Product Description
    The ARCHITECT c8000, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving, Texas
  • Manufacturer
    Abbott Laboratories, Inc

Manufacturer

Abbott Laboratories, Inc
  • Manufacturer Address
    Abbott Laboratories, Inc, 1921 Hurd Drive, PO Box 152020, Irving TX 75015-2020
  • Source
    USFDA