Events

Recall of BD ProbeTec CT / AC kit

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 BECTON DICKINSON.

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
    2005-07-08
  • 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-de-lots-du-dmdiv-kit-bd-probetec-ct-ac-becton-dickinson-diagnostic
  • 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 July 5, 2005, the Becton Dickinson Diagnostic Company withdrew from the market batches 4345728 (per 30.11.2005) and 4345733 (per 31.12.2005) of the in vitro diagnostic medical device called BD ProbeTec CT / AC kit reference 440474. This decision follows the identification of a risk of an increase in the number of false positive Chlamydia trachomatis results. This device allows the direct qualitative detection of Chlamydia trachomatis DNA from endocervical samples, urethral swabs. in humans and male and female urine samples, as evidence of C. trachomatis infection. The company has directly notified the recipients of the offending lots by means of the enclosed message (08 / 07/2005) (13 KB) validated by Afssaps. The European competent authorities concerned are informed directly by the manufacturer. This information is intended for laboratory managers, plant managers health authorities and to the correspondents of reactovigilance for dissemination, where appropriate, to the services concerned.

Device

BD ProbeTec CT / AC kit
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BECTON DICKINSON

Manufacturer

BECTON DICKINSON