Events

Rappel de therascreen PyroMark Gold Q24 Reagents and Pyro Buffers. An in vitro diagnostic medical device (IVD)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Qiagen Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2018-RN-00069-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-01-22
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00069-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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)
  • Modèle / numéro de série
    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