Events

Rappel de ID Anti-N and ID Anti-M/N. 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 Bio-Rad Laboratories 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-2016-RN-00373-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-04-07
  • 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-2016-RN-00373-1
  • 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
    It has been confirmed that in specific conditions, the anti-n (mns2) of certain lots of cards id-diaclon anti-n (ref. 007111) and id-diaclon anti-m/n (ref. 006011) may give an unexpected interference with n negative samples.Investigations have identified that this phenomenon is temperature dependent, becoming stronger if the ambient temperature drops to the lower range of room temperature, 18-25°c and tending to disappear once the temperature reaches the upper limit of this range. reagents and samples that are at the lower end of the room temperature range will also increase the interference.The reported issue may result in false positive results which can lead to a delay in transfusion decisions.
  • Action
    Bio-Rad is advising users NOT to validate a positive result that gives reaction strength lower than 3. The automatic validation function on the instruments should be disabled when carrying out tests MO45D and PR44N. Bio-Rad will provide manual test kits to confirm the results obtained for negative 1+ and 2+ reactions when requested. The sponsor is working on a permanent solution and the users will be notified once unaffected products become available. This action has been closed-out on 09/05/2017.

Device

ID Anti-N and ID Anti-M/N. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    ID Anti-N and ID Anti-M/N. An in vitro diagnostic medical device (IVD)ID-DiaClon Anti-N Catalogue Number: 007111Test Code (for instrument): PR44NLot Number: From lot 50221.73.01 onwardsID-DiaClon Anti-M/NCatalogue Number: 006011Test Code (for instrument): MO45DLot Number: From lot 51210.52.01 onwardsARTG Number: 217696
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd