Events

Recall of LES

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 SAYAG LES.

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
    1999-05-04
  • 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-de-tubes-standards-anticoagulants
  • 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 batches of standard anticoagulant tubes of the LES brand of SAYAG LES, whose references and batch numbers follow, are withdrawn from the market. Quality problems may render them, in whole or in part, unfit for their use and must not be used. The results obtained from the samples taken on these tubes are likely to be erroneous. Standard LES CITRATE anticoagulant tubes (potential presence of heparin, reference number CLVV05 / CLVV05NF / LES0221P 180207XX9x 190207XX9x 220207XX9x 230207XX9x 240207XX9x 250207XX9 .. LES2036N 250203XX9x 240203XX9x

Device

LES
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    SAYAG LES

Manufacturer

SAYAG LES
  • Source
    LAANSM