Events

Recall of Dimension® QuickLYTE Integrated Multisensor

According to L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), this recall involved a device in France that was produced by Dade-Behring.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Date
    2005-06-30
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    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 / Alerts
    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.
  • Extra notes in the data
  • 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
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Dade-Behring

Manufacturer

Dade-Behring
  • Source
    LAANSM