Events

Recall of Glucose reagent HK

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
    2006-04-13
  • 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-partiel-d-un-lot-du-reactif-glucose-hk-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
    On 10/04/06, the company ROCHE DIAGNOSTICS has withdrawn from the market the reagent bottles R2 lot 672 652 of the in vitro diagnostic medical device called glucose reagent HK, reference 11929542, whose numbers are between 12,943 and 13,822 following an abnormally high pH value due to accidental contamination during packaging, making it impossible to obtain a result. This device is used for the in vitro quantitative determination of glucose in human serum, urine and CSF. on Modular analyzers. The company ROCHE DIAGNOSTICS has directly notified the recipients of the offending lot by means of the attached message (10/04/2006) (49 KB) validated by Afssaps. The European competent authorities concerned are informed directly by the manufacturer. This information is intended for laboratory managers, the directors of health establishments and the reactovigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

Glucose reagent HK
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics