Events

Recall of ADVIA Centaur CA 19-9

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
    2004-08-30
  • 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-des-dmdiv-ca-19-9-advia-centaur-et-acs-180-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 27.08.04, Bayer Diagnostics withdrew from the market batches 75 (per 13.12.04) and 78 (per 22.02.05) of the in vitro diagnostic medical device known as ADVIA Centaur CA 19-9 - references 03481938 ( 250 tests) and 04612750 (50 tests) and lot 76 (per 24.12.04) of the in vitro diagnostic medical device called ACS: 180 - references 04412689 (300 tests) and 01569439 (50 tests), following the implementation of evidence of sensitivity to heterophile antibodies potentially present in patient samples larger than that of previous batches; this may lead to higher results than expected. These devices are used for the determination of the CA 19-9 tumor marker on the ADVIA Centaur and ACS: 180 analyzers.

Device

ADVIA Centaur CA 19-9
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BAYER DIAGNOSTICS

Manufacturer

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