Events

Recall of DMDIV Synchron

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
    2005-09-21
  • 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-synchron-r-systems-ast-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 16 September 2005, Beckman Coulter France SA withdrew lot T409085 (expiry 31/03/2006) from the in vitro diagnostic medical device called Synchron® Systems AST, Aspartate Aminotransferase with Pyridoxal-5'-phosphate reference 467849 This decision follows the highlighting of a printing error on the barcode label. As a result, the reagent will be identified as ALT (Alanine aminotransferase) on the screen and not as AST. This device is used for the quantitative determination of the activity of aspartate aminotransferase (AST) in serum or plasma. SYNCHRON LX® .. The company has directly notified the recipients of the offending batch by means of the enclosed message (16/09/2005) (130 KB) validated by Afssaps. The European Competent Authorities concerned are informed directly by the manufacturer. This information is intended for laboratory managers, health facility directors and reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

DMDIV Synchron
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BECKMAN COULTER

Manufacturer

BECKMAN COULTER