Events

Recall of Versant kPCR Molecular System Sample Preparation

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-00327-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-03-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00327-1
  • 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
    An issue has been identified regarding an unintended behaviour of the system's result-generation software. it has been observed that an internal control displayed a no baseline error but the assay result for that well was not reported as an invalid result. the correct software behaviour is to report the assay result as invalid result when the internal control for that well displays a no baseline error. this issue allows for the possibility that an incorrect assay result could be reported for a sample when the result should be invalid and the sample repeated. there is an extremely low risk of false negative results.
  • Action
    Siemens is advising users to review each report for the affected Versant IVD assays to identify if there are any No Baseline errors in the IC channel of any wells. If a No Baseline error occurs for the Internal Control of any well, users must not report the assay result for that well and repeat the test. A review of previously generated results is at the discretion of the Laboratory Director.

Device

Versant kPCR Molecular System Sample Preparation
  • Model / Serial
    Versant kPCR Molecular System Sample PreparationAffected Assays: HIV-1 RNA 1.5, HBV DNA 1.0, HCV RNA 1.0, CT/GC DNA 1.0 Siemens Material Number (SMN): 10282928All serial numbers affectedARTG Number: 175890An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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