Events

Recall of therascreen PyroMark Gold Q24 Reagents and Pyro Buffers. 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 Qiagen 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-2018-RN-00069-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-01-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00069-1
  • 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
    Qiagen have identified an increased number of cases with altered ratios in the pyrogram peak patterns for therascreen pyrosequencing assays. use of the affected lots is associated with an elevated invalidity and re-testing rate.In addition, use of the affected lots also creates an elevated risk of a59t false positive results for the pyrosequencing analysis of nras codon 59 with the therascreen ras extension pyro kit (ref 971590).In pyrosequencing runs performed with the affected material, the ratio of the peak height for datp peaks in pyrograms is artificially increased while in parallel the peak height for dgtp may be decreased. this may result in an altered ratio of peak heights and consequently leads to an incorrect determination of allele mutation frequencies.
  • Action
    Qiagen is advising users to discontinue use of the affected lots and contact Qiagen for replacement lots. Please ensure the corresponding assay Plug-in reports for automated result interpretation are used. If users have used the affected lots, it is strongly recommend a review of the corresponding results.

Device

therascreen PyroMark Gold Q24 Reagents and Pyro Buffers. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    therascreen PyroMark Gold Q24 Reagents and Pyro Buffers. An in vitro diagnostic medical device (IVD)PyroMark Gold Q24 ReagentsMaterial Number: 1055272Lot Numbers: 157010641, 157025615, 157027017, 157030977therascreen Pyro Buffers and ReagentMaterial Number: 1063948Lot Numbers: 157013230, 157013013, 157027507, 157028499, 157028495, 157030047, 157035803, 157033230ARTG Number: 226453 (Qiagen Pty Ltd - Acquired genetic alteration IVDs)
  • Manufacturer
    Qiagen Pty Ltd

Manufacturer

Qiagen Pty Ltd