Events

Recall of M634 Calibration Solution 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 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
    2005-05-06
  • 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-m634-ensemble-de-solution-d-etalonnage-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 03.05.2005, Bayer Diagnostics withdrew lot 5A030 from the in vitro diagnostic medical device called M634 Calibration Solution Kit Reference 09655784 following the detection of microbial contamination leading to a variation in the results of quality controls for pH, made by 634 pH / Ca2 + analyzers. This device is used with pH and calcium analyzers (models 634) .. The company has directly notified the recipients of the offending batch by means of the message herewith validated by the Afssaps (03/05/2005) (82 ko) .. This information is intended for laboratory managers, health facility directors and reactive vigilance correspondents for dissemination, where appropriate, to services concerned.

Device

M634 Calibration Solution Kit
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BAYER DIAGNOSTICS

Manufacturer

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