Events

Rappel de ImmunoCAP Allergen fx20, Food. 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 Abacus ALS 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-2017-RN-00222-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2017-02-21
  • 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-2017-RN-00222-1
  • 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
    Immunocap allergen fx20, food contains a mix of f4 (wheat), f5 (rye), f6 (barley), f9 (rice). due to a production non-conformity, certain lots of immunocap allergen fx20, food, may contain traces of oat (f7) allergen. this could cause false positive test results with regard to sensitisation to fx20 allergens for samples that are positive for oat allergen and negative for wheat, rye, barley, and rice allergens. however, this is an unlikely event because of the extensive cross-reactivity between the different cereal allergens and the low probability of monosensitisation to oat allergen in patients. therefore, it is unlikely that presence of oat allergen in immunocap allergen fx20 should result in incorrect test results for patient samples.
  • Action
    Abacus ALS is advising users of the possibility of false positives with the assay due to the presence of oat allergen. ImmunoCAP whole allergens f4, f5, f6 and f9 can be used as an alternative for testing of patient samples.

Device

ImmunoCAP Allergen fx20, Food. An in vitro diagnostic medical device (IVD).
  • Modèle / numéro de série
    ImmunoCAP Allergen fx20, Food. An in vitro diagnostic medical device (IVD).Lot Numbers: AAS0D (exp 31 Mar 2012)AAS0E (exp 31 Mar 2013)AAS0F (exp 31 May 2014)AAS0G (exp 30 Nov 2014)AAS0H (exp 31 Jan 2015)AASG1 (exp 31 Jul 2016)AASG2 (exp 30 Jun 2016)AASG3 (exp 30 Jun 2018)ARTG Number:186054
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd