Events

Recall of N Latex SAA

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
    2005-12-02
  • 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-n-latex-saa-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 30/11/2005, the company Dade Behring removed from the market lots 35442, 35730 and 35780 of the in vitro diagnostic medical device called N Latex SAA reference OQMP115. This device is used for the quantitative determination of Amyloid A Serum (AAS) in serum and human heparinized plasma on BN II and BN ProSpec systems. This measure follows the detection of a positive bias on the values ​​obtained with these batches of reagent, visualized by the quality controls. The company has directly notified the recipients of the incriminated batches by means of the attached message ( 02/12/2005) (12 ko) validated by Afssaps. This information is intended for laboratory managers, directors of health establishments and reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

N Latex SAA
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    DADE BEHRING

Manufacturer

DADE BEHRING
  • Source
    LAANSM