Events

Recall of COBAS INTEGRA Glucose HK Liquid cassette

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 Roche 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
    2001-10-23
  • 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-d-un-lot-de-cassettes-cobas-integra-glucl-de-la-societe-roche-diagnostics
  • 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 ROCHE DIAGNOSTICS removes from the market lot 624277 (per 31.03.02) of the in vitro diagnostic medical device called: COBAS INTEGRA Glucose HK Liquid cassette (GLUCL) - ref. 2055651/20763020, following nonconformity: decrease in linearity that can lead to obtaining default results without attention alarm. For the vast majority of Integra systems installed in France, the programming of the application dedicated to serum glucose (GLULF) allows to exclude the incidence of this anomaly on the determination of blood glucose. Regarding the urinary application (GLULU), a specific check is to be expected.

Device

COBAS INTEGRA Glucose HK Liquid cassette
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics