Events

Recall of CRP Bireactif

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 BIOTROL DIAGNOSTIC.

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
    2000-09-25
  • 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-de-reactif-denomme-crp-bireactif
  • 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
    Batches 113 and 115 of the reagent called CRP Bireactif - ref. B01744 from BIOTROL DIAGNOSTIC are withdrawn from the market due to an error in the concentration of PEG used for the manufacture of the buffer included in the reagent kit, leading to a risk of erroneous results for patient samples (over- or underestimation obtained from random way).

Device

CRP Bireactif
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BIOTROL DIAGNOSTIC

Manufacturer

BIOTROL DIAGNOSTIC
  • Source
    LAANSM