Events

Recall of Amoxicillin disks + Clavulanic acid

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 Bio-Rad.

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
    2003-02-03
  • 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-dispositif-medical-de-diagnostic-in-vitro-denomme-disques-d-amoxicilline-acide-clavulanique-ref-66178-par-bio-rad
  • 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
    Bio-Rad withdraws from the market batches 2M1387 (per 15.06.04) and 2M1388 (per 30.06.04) of the in vitro diagnostic medical device called: Amoxicillin disks + Clavulanic acid - reference 66178 (4x50 disks) , following a problem of stability of the formulation "Amoxicillin + Clavulanic acid". This device makes it possible to study the sensitivity of a bacterial strain to Amoxicillin + Clavulanic acid.

Device

Amoxicillin disks + Clavulanic acid
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Bio-Rad

Manufacturer

Bio-Rad