Events

Recall of Device Recall TDWorkstation

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

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
    67628
  • Event Risk Class
    Class 3
  • Event Number
    Z-1310-2014
  • Event Initiated Date
    2014-02-17
  • Event Date Posted
    2014-03-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125867
  • 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
    If a conflict occurs between a demography query and a result transmission by the instrument, the tdworkstation could send an incorrect patient demography to an instrument.
  • Action
    An email dated 2/17/14 was sent to their customers to inform them about concerns only if their site uses TDWorkstation and TD-Workstation Evolution products that meet all the listed criterias. The criterias are listed in the customer notification letter and it informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the reply form and return it by fax (514) 270-2770 with in 15 days from receiving the customer notification form. Customers that do not respond the reply form, Technidata will consider those customers do not wish to install the correction.

Device

Device Recall TDWorkstation
  • Model / Serial
    version 11.01.A or higher
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed in the state of PA.
  • Product Description
    TDWorkstation version 11.01.A or higher. TDWorkstation Evolution. || TDWorkstation receives patient results from a connected instrument and sends them to a Laboratory Information System (LIS).
  • Manufacturer
    Technidata S.A.

Manufacturer

Technidata S.A.
  • Manufacturer Address
    Technidata S.A., 387, Avenue Jean Kuntzmannn, Montbonnot St Martin France
  • Manufacturer Parent Company (2017)
    Technidata
  • Source
    USFDA