Events

Recall of Disposable Tips 1000 μl with filter

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 TECAN.

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
    2005-11-25
  • 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-dmdiv-disposable-tips-1000-l-with-filter-tecan
  • 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 17/11/2005, TECAN informed Afssaps of the withdrawal of lots U122098L-1325, U122098L-3225 and U122098L-2325 from the in vitro diagnostic medical device called Disposable Tips 1000 μl with filter reference 612 513.1. These are tips for Tecan Genesis .. reagents / sample dispensers. This measurement follows the discovery of a tip defect (presence of two filters instead of one) that may cause reactive sampling problems. / sample resulting in false negative or positive results. The company notified the users directly on 17/11/2005, by means of the attached message (25/11/2005) (16 KB). users, no tip of the aforementioned lots was used in the context of a diagnosis. Therefore, this withdrawal does not require patient-specific measures. The relevant European Competent Authorities are informed directly by the manufacturer. This information is intended for laboratory managers, the directors of health establishments and health and safety correspondents. dissemination, where appropriate, to the services concerned.

Device

Disposable Tips 1000 μl with filter
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    TECAN

Manufacturer

TECAN
  • Source
    LAANSM