Events

Rappel de ZYM B, API Listeria and API NH (bacterial identification reagents and kits). 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 Biomerieux Australia 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-2013-RN-01186-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-11-14
  • 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-2013-RN-01186-1
  • 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
    Biomérieux identified a visual defect and activity issue on the zym b reagent (reference 70493) which is used as an additional test for revealing the results of some miniaturised biochemical tests. further investigations performed by biomerieux quality control laboratory confirmed an activity issue on zym b reagent. this activity issue lead to a false negative result of some api biochemical tests using the zym b reagent. investigations are still in progress in order to identify the root cause.
  • Action
    BioMerieux is advising end users to discard any ampoule of ZYM B with a visual defect (as described in the IFU). For units of ZYM B without the visual defect, end users are requested to carry out additional QC when using the potentially affected API kits. If QC fails the kits are to be discarded. Alternatively any kits of ZYM B can be discarded and replaced by bioMerieux.

Device

ZYM B, API Listeria and API NH (bacterial identification reagents and kits). An in vitro diagnost...
  • Modèle / numéro de série
    ZYM B, API Listeria and API NH (bacterial identification reagents and kits). An in vitro diagnostic medical device (IVD)ZYM B reagent (Ref Number: 70493)Multiple lot numbers affectedUsed as an additional test in:- API 20 Strep (Ref Number: 20600)- API Coryne (Ref Number: 20900)- API Staph (Ref Number: 20500)- API ZYM (Ref Number: 25200)API NH (Ref Number: 10400)Multiple lot numbers affectedAPI Listeria (Ref Number: 10300)Multiple lot numbers affected
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd