Events

Recall of MULTI-4 CO-OXIMETER CONTROL;CMV IHA AUTO

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 INSTRUMENTATION LABORATORY.

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
    1999-01-13
  • 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-des-reactifs-denommes-multi-4-co-oximeter-control-et-cmv-iha-auto-retrait-de-tous-les-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
    All lots of the reagents called "MULTI-4 CO-OXIMETER CONTROL" and "CMV IHA AUTO", from the company INSTRUMENTATION LABORATORY are withdrawn from the market. These reagents have not been registered in accordance with Article L.761-14-1 of the Public Health Code at the French Medicines Agency. The lack of registration of a reagent does not allow its services to evaluate the performance criteria and reliability of the reagent, which can lead to risks to public health.

Device

MULTI-4 CO-OXIMETER CONTROL;CMV IHA AUTO

Manufacturer

INSTRUMENTATION LABORATORY
  • Source
    LAANSM