Events

Recall of IChem 10 SG Urine Chemistry Strips

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 Iris Diagnostics.

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
    2015-01-07
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/bandelettes-de-chimie-urinaire-ichem-10-sg-iris-diagnostics-rappel-de-lots
  • 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
    The company BECKMAN-COULTER informed the users of iChem 10 SG urinary chemistry strips of the recall of 4 batches. The users concerned, in France, received the attached mail (07/01/2015) (71 KB). This information is addressed to the directors of health establishments and local correspondents of reactovigilance for diffusion to the concerned services.

Device

IChem 10 SG Urine Chemistry Strips
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Iris Diagnostics

Manufacturer

Iris Diagnostics