Events

Rappel de Liquichek Urine Chemistry Control Level 2 and Liquichek Urine Chemistry Control MiniPak (contains Level 2). 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-2018-RN-00495-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-05-17
  • 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-00495-1
  • 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
    Bio-rad have received multiple customer complaints indicating that some analyte values in certain vials of liquichek urine chemistry control level 2, lot 68512, are recovering outside the package insert stated ranges, namely high cvs.The performance of level 1, lot 68511 is not impacted.To date, there have been no reports of injury or illness as a result of this issue.
  • Action
    Bio-Rad is advising customers to inspect and quarantine affected units to prevent further use. Customers are advised to discard any remaining inventory of Liquichek Urine Chemistry Control, Level 2 Lot 68512 and MiniPak 395X Lot 68510 (that contains the level 2). Users are advised to contact Bio-Rad to make arrangements for replacement or to alter any pending orders or shipments. The replacement stock of Liquichek Urine Chemistry Control Level 2 is Lot 65822.

Device

Liquichek Urine Chemistry Control Level 2 and Liquichek Urine Chemistry Control MiniPak (contains...
  • Modèle / numéro de série
    Liquichek Urine Chemistry Control Level 2 and Liquichek Urine Chemistry Control MiniPak (contains Level 2). An in vitro diagnostic medical device (IVD)Liquichek Urine Chemistry Control Level 2Catalogue Number: 398Lot Number: 68512Expiry Date: 30 Sept 2019Liquichek Urine Chemistry Control MiniPak (contains Level 2)Catalogue Number: 395XLot Number: 68510Expiry Date: 30 Sept 2019ARTG Number: 206309(Bio-Rad Laboratories - Clinical chemistry biological screening IVDs)
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd