Events

Recall of Device Recall TDHisto/Cytology

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
    65652
  • Event Risk Class
    Class 3
  • Event Number
    Z-1743-2013
  • Event Initiated Date
    2013-06-20
  • Event Date Posted
    2013-07-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119817
  • 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
    A recall was initiated by technidata because use of symbols (less than or equal to or greater than or equal to or any other symbol) in microsoft word reports when using electronic transmissions of results by of hprim (including hprim medecin via kermit) or hl7 must be absolutely prohibited. such symbols are not supported by the microsoft word interface used by the histology/cytology software and.
  • Action
    TD Technidata Medical Software sent a Medical Device Recall letter dated June 20, 2013, to one affected customer who received the TD-Synergy Histology/Cytology module. The customer was informed of the problems identified and the actions to be taken. Customers were instructed to complete the attached Reply Form and return it to the firm by fax to 514-270.2770. The customer were also instructed to contact Technidata Canada at (514) 270-7777 or at support-canada@technidata-web.com.

Device

Device Recall TDHisto/Cytology
  • Model / Serial
    All TDHistology/Cytology product versions.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution CA only.
  • Product Description
    TDHistology/Cytology || Classification name: Calculator/data processing module for clinical use (862.2100). Intended use: Laboratory Information System (L.I.S)
  • 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