Events

Recall of Device Recall VITROS WorkCentre with enGen system

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ortho-Clinical Diagnostics.

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
    36184
  • Event Risk Class
    Class 3
  • Event Number
    Z-0077-2007
  • Event Initiated Date
    2006-03-06
  • Event Date Posted
    2006-10-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-06-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48146
  • 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
    Work Center - Product Code JQP
  • Reason
    Incorrect result calculations can occur (only affects derived results calculated by the vitros workcentre).
  • Action
    On 3/06/06, all domestic end-users were sent "URGENT PRODUCT CORRECTION NOTIFICATION" letters (dated 3/06/06) by fax and FedEx, informing the users of the problem. The users were also notified by phone. OCD also notified its affiliates in France and the UK of the issue for notifying their customers of the problem.

Device

Device Recall VITROS WorkCentre with enGen system
  • Model / Serial
    Catalog # 6802159
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution ---- USA including states of DE, TN, MI, and AZ and countries of United Kingdom and France.
  • Product Description
    VITROS¿ WorkCentre, Catalog # 6802159, using enGen" Series Automation Systems (Catalog # ENGEN). VITROS WorkCentre is Ortho-Clinical Diagnostics, Inc.''s branded version of Instrument Manager" developed & listed by Data Innovations, Inc. of South Burlington, VT. --- Ortho-Clinical Diagnostics, Rochester, NY.
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Manufacturer Address
    Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester NY 14626
  • Source
    USFDA