Events

Recall of Chemiluminescent Substrate reagent

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 Siemens.

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
    2009-06-17
  • 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-de-reactifs-de-substrat-chimiluminescent-societe-siemens-healthcare
  • 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
    In agreement with Afssaps, Siemens Healthcare informed the users of the Chemiluminescent Substrate reagent on 12/06/09 of the withdrawal of several batches of reagent due to a lack of performance. If this reagent is used in the context of prenatal trisomy 21 screening, the lack of performance leads to an increased value of the risk calculation. The users of this device concerned by this defect, in France, received the attached mail (17/06/2009) (47 KB) accompanied by Afssaps recommendations for laboratories performing prenatal screening for trisomy 21. The competent European authorities have been informed of this measure by the manufacturer. This information is intended for laboratory managers, directors of health establishments and local correspondents of reactive vigilance for distribution to the concerned biology departments.

Device

Chemiluminescent Substrate reagent
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Siemens

Manufacturer

Siemens
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    LAANSM