Events

Recall of 96 Deep Well Plate 2mL (used on the VERSANT kPCR Sample Preparation and Tissue Preparation System)

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-2015-RN-01257-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-12-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01257-1
  • 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 is providing this communication to customers regarding a defect observed in the deep well plate used on the versant kpcr sample preparation and tissue preparation systems. multiple plates in lot 143449 have been observed to have extraneous plastic in the interior of the well at position f7 of the plate. if present, this extraneous plastic may cause a jam of the 1 ml pipet tip during dispense of reagent. the jamming of the pipet tip may result in a failure of the run. this failure will prevent the reporting of any patient results from that run and the samples must be repeated.
  • Action
    Siemens is advising users to inspect stock and to discontinue use and discard any of the affected lot. Siemens is advising users that the review of previous patient data is at the discretion of the Laboratory Director. This action has been closed-out on 17/05/2017.

Device

96 Deep Well Plate 2mL (used on the VERSANT kPCR Sample Preparation and Tissue Preparation System)
  • Model / Serial
    96 Deep Well Plate 2mL (used on the VERSANT kPCR Sample Preparation and Tissue Preparation System)Siemens Material Number: 10283255Lot Number: 143449ARTG 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