Events

Recall of SERVIRapide MULTIPARAMETER 4-M-AMP

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 ServiBio.

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
    2005-08-08
  • 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-du-dmdiv-servirapide-multiparametre-4-m-amp-servibio
  • 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 ServiBio informed Afssaps of the withdrawal of lot 29104-05 of the In Vitro Diagnostic Medical Device called SERVIRapide MULTIPARAMETER 4-M-AMP references KD637 and KD737 .. This decision follows the possibility of obtaining false negative results . This device is a one-step solid-phase immunochromatographic test for the detection of Cannabis, Morphine, Cocaine and Methamphetamine in the urine. 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

SERVIRapide MULTIPARAMETER 4-M-AMP
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    ServiBio

Manufacturer

ServiBio
  • Source
    LAANSM