Events

Recall of ADVIA 120 Timepac Formula

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
    2002-10-10
  • 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-reactif-advia-120-timepac-formule-reference-t01-3621-52-de-la-societe-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
    Bayer Diagnostics withdraws lot V66542 from the market named ADVIA 120 Timepac Formula / reference T01-3621-52 due to a risk of increased neutrophil leukocyte peroxidase staining (in this case, the proportion of eosinophils can be overestimated by mistake by about 2% and that of neutrophils, underestimated by 2%). This reagent is used for the determination of certain hematological constants (Perox leukocyte count, percentage of neutrophil granulocytes, lymphocytes, monocytes, etc.) on the Bayer ADVIA 120 hematology automaton.

Device

ADVIA 120 Timepac Formula
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BAYER DIAGNOSTICS

Manufacturer

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