Events

Rappel de Dimension® QuickLYTE Integrated Multisensor

Selon L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), ce/cet/cette rappel concerne un dispositif en/au/aux/à France qui a été fabriqué par Dade-Behring.

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
  • Date
    2005-06-30
  • Pays de l'événement
    France
  • Source de l'événement
    ANSM
  • URL de la source de l'événement
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-du-dmdiv-dimension-r-quicklyte-integrated-multisensor-dade-behring
  • Notes / Alertes
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Notes supplémentaires dans les données
  • Action
    On 28 June 2005, the company Dade-Behring withdrew lots 5BD812 (28.08.2005), 5DD820 (18.10.2005), 5CD813 (07.09.2005) and 5DD821 (25.10.2005). ), 5CD816 (dated 28.09.2005), 5DD828 (dated 11.10.2005), 5DD817 (dated 04.10.2005) of the in vitro diagnostic medical device called Dimension® QuickLYTE Integrated Multisensor reference S600 .. This decision follows the possibility of obtaining results of urinary chlorine (patient and quality control) having a positive bias of 10 to 50%. This device is used for the quantitative measurement of sodium, potassium, chlorine and total carbon dioxide in serum and heparinized plasma and to the quantitative measurement of sodium, potassium and chlorine in the urine. The company has directly notified the recipients of the offending lots by means of the attached message (28/06 / 2005) (12 KB) validated by Afssaps .. The relevant European Competent Authorities are informed directly by the manufacturer. This information is intended for laboratory managers, directors of health establishments and reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

Dimension® QuickLYTE Integrated Multisensor
  • Modèle / numéro de série
  • Description du dispositif
    in-vitro_medical_device
  • Manufacturer
    Dade-Behring

Manufacturer

Dade-Behring
  • Source
    LAANSM