Events

Recall of MicroCel® 300/500/700 Buffer Chamber (Buffer tank for MicroCel® 300 , 500, 700)

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 BAYER 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
    2004-09-24
  • 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-microcel-buffer-chamber-de-par-bayer-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 September 22, 2004, Bayer Diagnostics withdrew from the market batches manufactured between July 23, 2003 and July 31, 2004 of the in vitro diagnostic medical device called MicroCel® 300/500/700 Buffer Chamber (Buffer tank for MicroCel® 300 , 500, 700) - references 03974365 (VG42044) / 09830144 (VG42115) / 03541434 (VG42046) following the detection of a possible leakage that could lead to arcing (risk for the user) .. This device (Buffer tank) is part of the OpenGene® system's Long Read Tower sequencer (system for nucleic acid sequencing).

Device

MicroCel® 300/500/700 Buffer Chamber (Buffer tank for MicroCel® 300 , 500, 700)
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BAYER DIAGNOSTICS

Manufacturer

BAYER DIAGNOSTICS
  • Manufacturer Parent Company (2017)
    Bayer AG
  • Source
    LAANSM