Events

Recall of syngo Lab Data Manager. Middle-ware for use with in vitro diagnostic medical devices (IVD).

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Ltd Diagnostics Division.

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
    RC-2014-RN-00574-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-05-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00574-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    In the assay details screen, certain configuration parameters selected during configuration of reference ranges for assays may cause the reference ranges to not hold results as expected. this may cause the release of results to the laboratory information system (lis) that should have been held for manual review.
  • Action
    Siemens is notifying hospitals and laboratories of specific limitations with the use of sample reports in the syngo Result Manager that have not been previously communicated in the Operator's Guide.

Device

syngo Lab Data Manager. Middle-ware for use with in vitro diagnostic medical devices (IVD).
  • Model / Serial
    syngo Lab Data Manager. Middle-ware for use with in vitro diagnostic medical devices (IVD).Software Versions: VA11B, VA12A, VA12BSiemens Material Numbers: 10800057, 10803189, 1084573
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA