Events

Recall of ADVIA Chemistry Theophylline_2 Reagent

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

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-2016-RN-00831-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-06-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00831-1
  • 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 healthcare diagnostics has identified that the advia chemistry theophylline_2 (theo_2) reagent lot 334018 used on the advia 1200, 1800, 2400, and xpt chemistry systems may exhibit increased imprecision for commercially available tdm quality controls and patient specimens.Siemens internal investigation after one internal complaint was received confirmed that reagent lot 334018 is not in statistical alignment with the representative precision data published in the ifu and the design input requirements on the advia chemistry systems.Discordance with the clinical presentation is expected to lead to repeat testing or more frequent monitoring. there may be a delay in theophylline testing due to troubleshooting after failed qc.
  • Action
    Siemens is advising users to discontinue use of and discard the kit lot. Siemens is recommending that a review of previously generated results is considered.

Device

ADVIA Chemistry Theophylline_2 Reagent
  • Model / Serial
    ADVIA Chemistry Theophylline_2 ReagentTest Code: THEO_2Catalogue Number: 10377503Lot Number: 334018Expiration Date: Sept 2017ARTG Number: 175699An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA