Events

Recall of PhoenixSpec Calibrator 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 BD Diagnostics.

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
    2005-12-22
  • 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-bd-phoenixspec-calibrator-kit-bd-diagnostics
  • 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    On 20/12/2005, the company BD Diagnostics has withdrawn lots 5075281 and 5115146 from the in vitro diagnostic medical device called BD PhoenixSpec Calibrator Kit reference 440911. This device is used for the calibration of the BD PhoenixSpec Nephelometer which allows the measurement turbidity of microbial suspensions equivalent to McFarland standards 0.10-4.50. This decision follows the detection of a problem of stability drift of the 0.25 MacFarland calibration tube contained in the aforementioned kits that could lead to a bad calibration of the device BD PhoenixSpec Nephelometer identified by an error message "CAL?" In addition, the manufacturer also reports that the Nephelometer Operator's Manual will be changed to the "CAL?" Error message. The company has directly notified the recipients of the incriminated lots by means of the message attached (20/12/2005) (16 KB) validated by Afssaps. The competent European authorities concerned are informed directly by the manufacturer. 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

PhoenixSpec Calibrator Kit
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BD Diagnostics

Manufacturer

BD Diagnostics