Events

Recall of CLINITEK 50

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
    2003-05-27
  • 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-quelques-analyseurs-clinitek-50-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
    The company BAYER Diagnostics withdraws from the market the serial numbers between 168252 and 168292 of the in vitro diagnostic medical device called: CLINITEK 50, urinary chemistry analyzers (reference: 00566193). In fact, some analyzers may have malfunctions (error code) or give erroneous results if they are connected to mains without earth connection. The CLINITEK 50 analyzer, in combination with reagent strips, allows the semi-quantitative determination, in the urine, of the following parameters: nitrite, pH, density, bilirubin, urobilinogen, glucose, ketone bodies, proteins, microalbumin, leucocytes, blood .. The users concerned were contacted directly.

Device

CLINITEK 50
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BAYER DIAGNOSTICS

Manufacturer

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