Events

Recall of VITROS / reagent cartridge 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 ORTHO CLINICAL 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
    2001-11-30
  • 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-du-reactif-vitros-cartouche-de-reactifs-ca-19-9-de-la-societe-ortho-clinical-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 Ortho Clinical Diagnostics withdraws from the market batches 130 (per.01.12.01) and 140 (per.27.01.02) of the in vitro diagnostic medical device called: VITROS / reagent cartridge CA 19-9 - references 6800040, continued to obtain overestimated results for patient samples (average overestimation of + 40% over the range from 3.1U / ml to 760U / ml, variable depending on the concentration zone and ranging from + 2% to +100 %)

Device

VITROS / reagent cartridge CA 19-9

Manufacturer

ORTHO CLINICAL DIAGNOSTICS