Events

Recall of Device Recall TDSynergy

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
    56447
  • Event Risk Class
    Class 2
  • Event Number
    Z-1345-2013
  • Event Initiated Date
    2010-07-29
  • Event Date Posted
    2013-05-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93696
  • 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
    Technidata has discovered that using the f8 key in the erm session to add a combined test can result in the modification of the value of a result that has already been entered for a test of the request.
  • Action
    The firm, Technidata, sent an "P1 DEFECT INFORMATION" notice dated July 2, 2010 to their consignee/customers. The notice describes the product, problem and actions to be taken. The notice directs them to find the correction to the software issue on the Technidata website where they are able to install the correction kit depending on the version and operating system used. Note "You must back up the database and the installation directory before installing this correction". Should you need any further information, do not hesitate to contact the Support team at +33 (0) 4 76 04 13 00.

Device

Device Recall TDSynergy
  • Model / Serial
    TD Lims product versions: LIS (ALLX)-21.041-_ML-5370, LIS (ALLX)-22.021-_ML-5374, TD-Synergy product versions: SYN (ALLX)- 03.13B-_ML-5368, SYN (ALLX)- 03.141-_ML-5369, SYN(LINUX)-06.011-_ML-5381, SYN (ALLX)-11.11B-_ML-5345, SYN (ALLX)-11.21B-_ML-5346 SYN (ALL)- 11.31C-_ML-5372, SYN (LINUX)-11.321-_FR-5382, SYN (ALL)-11.321-_ML-5373
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including Washington DC and the states of California, Nevada, Kentucky, Alabama, Rhode Island, Pennsylvania, and Louisiana and the country of Italy.
  • Product Description
    TD-Synergy. || Laboratory Information System.
  • 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