Events

Recall of Phenobarbitol Reagent (used with ADVIA Chemistry System). 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-2012-RN-01179-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-11-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01179-1
  • 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
    Internal studies have indicated there is an error which may cause control values and/or patient values to be increased or decreased by as much as 30%.
  • Action
    Siemens Healthcare is asking customers to discontinue use and dispose the affected stock. A review of previously generated results should be undertaken at the discretion of the Laboratory Director.

Device

Phenobarbitol Reagent (used with ADVIA Chemistry System). An in vitro diagnostic medical device (...
  • Model / Serial
    Phenobarbitol Reagent (used with ADVIA Chemistry System). An in vitro diagnostic medical device (IVD)Phenobarbitol Reagent (PHNB_2)Catalogue Number: 10377505Lot Numbers: 244574, 256536ARTG Number: 176643An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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