Events

Recall of Ortho HTLV-I / HTLV-II Ab-Capture 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
    2002-11-27
  • 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-des-lots-htv149-et-htv150-du-dispositif-medical-de-diagnostic-in-vitro-denomme-ortho-htlv-i-htlv-ii-ab-capture-elisa-test-system-par-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
    Ortho Clinical Diagnostics withdraws from the market HTV149 (per.04.04.03) and HTV150 (per.05.06.03) batches of the in vitro diagnostic medical device known as: Ortho HTLV-I / HTLV-II Ab-Capture ELISA Test System - reference 934200, following the possible presence of flocculates in the control vials (negative and positive) included in the boxes .. to note: this defect does not interfere with the performance of the tests; this device is used to detect antibodies against HTLV-I and / or HTLV-II viruses in human serum and plasma.

Device

Ortho HTLV-I / HTLV-II Ab-Capture ELISA Test System

Manufacturer

ORTHO CLINICAL DIAGNOSTICS