Events

Recall of Dimension® PBNP Calibrator

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 Dade-Behring.

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-d-un-lot-du-dmdiv-calibrateur-dimension-r-pbnp-dade-behring
  • 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 24/11/2005, the company Dade-Behring withdrew from the market lot 5FD038 (per 01/06/2006) of the in vitro diagnostic medical device called Calibrator Dimension® PBNP reference RC423. This device is a calibrator for the calibration of the PBNP method, for the quantitative determination of the N-terminal proBNP (natriuretic peptide type B) in human plasma on the Dimension® clinical chemistry system. A previous withdrawal dated November 3, 2005 occurred on lot 5BD009 for a stability defect of the PBNP Calibrator resulting in a positive bias on the quality control values ​​after recalibration and as a consequence an overestimation of the patient results. Following this previous withdrawal and new reports, the validity of the Calibrator before opening has been redefined at 5 months and therefore lot 5FD038 has reached this new validity limit. The company has directly notified the recipients of the offending lot by means of the attached message (24/11/2005) (19 KB) validated by Afssaps. The relevant European Competent Authorities are informed directly by the competent authority of the United Kingdom, MHRA .. This information is intended for laboratory managers, directors of health establishments and reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

Dimension® PBNP Calibrator
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Dade-Behring

Manufacturer

Dade-Behring
  • Source
    LAANSM