Events

Recall of Triglycerides

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 OLYMPUS France.

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
    2003-01-28
  • 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-olympus-triglycerides-reference-osr6133
  • 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 OLYMPUS France withdraws from the market batches 9778, 9779, 9785 of the reference OSR6133 of the in vitro diagnostic device called OLYMPUS Triglycerides following a problem of stability of the enzyme (glycerol kinase) present in the reagent R1 contained in the box . The degradation of this enzyme leads to a slowing of the kinetics of the reaction, the results of the samples having a triglyceride concentration higher than 10 g / l can be affected (decrease).

Device

Triglycerides
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    OLYMPUS France

Manufacturer

OLYMPUS France