Events

Recall of Reagents B12 AxSYM

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 ABBOTT Diagnostic.

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
    2001-03-16
  • 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-reactif-denomme-reactifs-b12-axsym
  • 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
    Lots 71097M100 (per 30.05.01) and 71098M10 (per 30.05.01) of the reagent called Reagents B12 AxSYM - ref. 3C79-20 of the company ABBOTT Diagnostic are withdrawn from the market following the risk of failure of calibrations or patient results and non-reproducible controls. To note: no impact for the patient; in fact, the manipulations are invalidated by the failure of the calibration or by the out-of-specification checks.

Device

Reagents B12 AxSYM
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    ABBOTT Diagnostic

Manufacturer

ABBOTT Diagnostic
  • Source
    LAANSM