Events

Recall of Leucoprotective Diluent for CELL-DYN® 3200

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 ABBOTT 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
    2004-10-07
  • 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-diluant-leucoprotecteur-pour-cell-dyn-3200-de-par-abbott
  • 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
    Abbott Diagnostic withdraws lots 14465 I2 (per 28.02.05) from the market; 15597 I2 (31.03.05); 15598 I2 (31.03.05); 16753 I2 (30.04.05) and 17947 I2 (per 31.05.05) of the in vitro diagnostic medical device called Leucoprotective Diluent for CELL-DYN® 3200 - reference 3H79-01 following the detection of a possible high background - higher than specifications - on platelets .. A note. :. - the patient results returned, obtained with these device lots, are valid if the background noise was in the specifications. the investigations conducted by the manufacturer have identified a contamination with a high-boiling oil which can form, over time and under the effect of stirring, an emulsion causing the rise of the background noise on the wafers. Corrective measures have been put in place. The company Abbott Diagnostic has directly informed the recipients of the incriminated lots. This information is addressed to the directors and correspondents of réactovigilance for diffusion, if necessary, to the services concerned.

Device

Leucoprotective Diluent for CELL-DYN® 3200
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    ABBOTT DIAGNOSTIC

Manufacturer

ABBOTT DIAGNOSTIC
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    LAANSM