Events

Recall of TD-SYNERGY

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by TECHNIDATA S.A.S..

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
    46407
  • Event Risk Class
    II
  • Event Initiated Date
    2008-11-04
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    If a test with a known result is inserted in a patient request via a connection or manually via erm and this test contains a rule... this defect could affect patient results and could cause improper diagnosis.

Device

TD-SYNERGY
  • Model / Serial
    Model Catalog: TD-SYN-01 (Lot serial: TD-Synergy V03.13.1 all UNIX); Model Catalog: TD-SYN-01 (Lot serial: TD-Synergy V03.12.B all UNIX); Model Catalog: TD-SYN-01 (Lot serial: TD-Synergy V05.01.B all UNIX); Model Catalog: TD-SYN-01 (Lot serial: TD-Synergy V05.02.1 all UNIX); Model Catalog: TD-SYN-01 (Lot serial: TD-Synergy V11.01.1 all UNIX); Model Catalog: TD-SYN-01 (Lot serial: TDLims V21.04.1 for HP-UX AIX); Model Catalog: TD-SYN-01 (Lot serial: TDLims V22.02.1 for AIX SunOS); Model Catalog: TD-SYN-01 (Lot serial: TD-Synergy V11.11.1 all UNIX)
  • Product Description
    TD-Synergy Software (TD-SYN-01)
  • Manufacturer
    TECHNIDATA S.A.S.

Manufacturer

TECHNIDATA S.A.S.
  • Manufacturer Address
    MONTBONNOT SAINT MARTIN
  • Manufacturer Parent Company (2017)
    Technidata
  • Source
    HC