Recall of aca / Vancomycin

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
    2003-01-24
  • Event Country
  • Event Source
    ANSM
  • Event Source URL
  • 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
    DADE BEHRING withdraws from the market lot A2266B (per 01.03.03) of the in vitro diagnostic medical device called: aca / Vancomycin - reference 735918901, following the detection, for the plasma samples, of a positive bias compared to other commercialized techniques. This device makes it possible to measure vancomycin in serum and plasma samples. This assay is used to monitor vancomycin treatments in certain patients (dialysis, burns, etc.) for the diagnosis and treatment of vancomycin overdosage.

Device

  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer

Manufacturer

  • Source
    LAANSM