Events

Recall of ADVIA 1200, 1650, 1800 and 2400 Clinical Chemistry Systems. An in vitro diagnostic medical device (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-2013-RN-00933-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-09-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00933-1
  • 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
    Siemens has confirmed that the affected advia chemistry systems will report results calculated using the ratio parameters feature without error flags when underlying individual test results used as part of the calculation are flagged. in cases where an error flag suppresses a numerical result, a ratio calculation will not be performed. if a numerical result is generated with a flag, the ratio will be reported without a flag.
  • Action
    End users are requested to ensure that all ratio tests should be reviewed for flags prior to approving. Siemen's is developing a new version of software that will introduce a new flag for all ratio results that have a flag on a component test.

Device

ADVIA 1200, 1650, 1800 and 2400 Clinical Chemistry Systems. An in vitro diagnostic medical device...
  • Model / Serial
    ADVIA 1200, 1650, 1800 and 2400 Clinical Chemistry Systems. An in vitro diagnostic medical device (IVD)Siemens Reference Number: CHSW 13-01ARTG Number: 174383
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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