Events

Rappel de Randox Liquid Cardiac Controls when used with CKMB and Myoglobin assays. 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 Randox 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-2017-RN-00632-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-05-29
  • 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-00632-1
  • 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
    Randox has confirmed a change in recovery with regards to ckmb in lot 3912ck (expiry 28 october 2017) of the liquid cardiac control 3. a similar issue with myoglobin has previously been reported for this lot (recall for product correction, notice 284 dated 17th feb 2017, tga ref. rc-2017-rn-00340-1). all other analytes recover as expected. taking into consideration the other related previously issued recall for product correction (notice 284) for the liquid cardiac controls 1, 2 & 3, the ifu for each of these controls has been updated to indicate in the storage and stability section that values for ckmb and myoglobin may gradually decrease over the product shelf-life for the liquid cardiac controls. this limitation applies to specific lots that have been supplied and to all future lots of liquid cardiac controls. if the control material is affected it is apparent immediately as the value will not fall within the assigned range.
  • Action
    Randox is providing users with a notice and revised IFU template that states that CKMB and Myoglobin values in CQ5051, CQ5052 and CQ5053 may gradually decrease over the shelf life of the products. Users are to place the notice and revised IFU in the kit of all affected Liquid Cardiac Control products.

Device

Randox Liquid Cardiac Controls when used with CKMB and Myoglobin assays. An in vitro diagnostic m...
  • Modèle / numéro de série
    Randox Liquid Cardiac Controls when used with CKMB and Myoglobin assays. An in vitro diagnostic medical device (IVD)Liquid Cardiac Control 1Catalogue Number: CQ5051Batch Numbers: 3909CK, 3913CK (exp. 28 Oct 2017), 3987CK (exp. 28 Apr 2018)Liquid Cardiac Control 2Catalogue Number: CQ5052Batch Numbers: 3911CK (exp. 28 Oct 2017), 3991CK (exp. 28 Apr 2018)Liquid Cardiac Control 3Catalogue Number: CQ5053Batch Numbers: 3912CK (exp. 28 Oct 2017)ARTG Number: 208141
  • Manufacturer
    Randox Australia Pty Ltd

Manufacturer

Randox Australia Pty Ltd
  • Source
    DHTGA