Events

Recall of Ortho HIV-1 / HIV-2 Capture Ab ELISA Test System

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
    2002-07-25
  • 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-ortho-hiv-1-hiv-2-ab-capture-elisa-test-system-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 the lot HVK163 (per 09.01.03) of the in vitro diagnostic medical device called Ortho HIV-1 / HIV-2 Capture Ab ELISA Test System - references 932360/932380, following the presence of flocculates in the negative and positive control vials included in the packs. This anomaly does not interfere with the performance of controls and tests. This device is used in the context of the detection of anti - HIV - 1 and anti - HIV - 2 antibodies.

Device

Ortho HIV-1 / HIV-2 Capture Ab ELISA Test System

Manufacturer

ORTHO CLINICAL DIAGNOSTICS