Events

Recall of Reagent B27-FITC / B7-PE

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 BECKMAN COULTER.

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
    2005-07-25
  • 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-d-un-lot-du-dmdiv-reactif-b27-fitc-b7-pe-de-beckman-coulter
  • 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 22 July 2005, Beckman Coulter withdrew from the market lot 6 (expiry 01/08/2007) of the in vitro diagnostic medical device called reagent B27-FITC / B7-PE, reference A07739 following the implementation of Evidence of variations in performance from one vial to another may be the source of false positive results. This device is used to demonstrate the expression of HLA-B27 antigen on leukocytes. This highlighting assists in the diagnosis of ankylosing spondylitis. The company Beckman Coulter directly warned the recipients of the offending batch by means of the attached message (22/07/2005) (23 KB) validated by the Afssaps . The competent European authorities concerned are informed directly by the manufacturer. This information is intended for medical biology laboratory managers, health facility directors and reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

Reagent B27-FITC / B7-PE
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BECKMAN COULTER

Manufacturer

BECKMAN COULTER