Events

Recall of Kit de confirm HBs Ag

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
    2005-12-26
  • 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-dmdiv-kit-de-confirmation-ag-hbs-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
    On 23/12/2005, Ortho-Clinical Diagnostics withdrew from the market the batch 240 (03/04/2006) and 250 (03/07/2006) of the in vitro diagnostic medical device called Kit de confirm HBs Ag reference 822 8595. This device is used to confirm the presence of hepatitis B virus surface antigen (HBsAg) in human serum and plasma samples (EDTA, heparin or citrate ) found to be repeatable with the Vitros Ag HBs test. This is due to the fact that the sample diluent produces a higher background that may lead to unconfirmed (false negative for HBsAg) results for samples with has given positive results with the Vitros HBs Ag test. This risk concerns only previously diluted samples, that is to say, samples that have obtained a Vitros HBs Ag positive test result> 500 S / C. The company has directly notified the recipients of the offending batches by means of the enclosed message (26/12/2005) (101 KB) validated by Afssaps. The European competent authorities concerned are informed directly by the manufacturer. This information is intended for laboratory managers, health facility directors and reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

Kit de confirm HBs Ag

Manufacturer

Ortho-Clinical Diagnostics