Events

Alerte Ou Avis De Sécurité sur Intrinsic Factor Antibody test strips used in testing for vitamin B12 malabsorption, Alegria Anti-Intrinsic Factor Assay (ORG-247-24)

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Orgentec Diagnostika GmbH.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • ID de l'événement
    MDA/2013/041
  • Numéro de l'événement
    CON286935
  • Date
    2013-06-19
  • Date de publication de l'événement
    2013-06-19
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON286935?tabName=allTabs
  • Notes / Alertes
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notes supplémentaires dans les données
  • Cause
    Deterioration in the activity of affected lots may lead to false negative results outside of the manufacturer’s claims for performance (61.2% sensitivity). a false negative could result in a delay in diagnosis or treatment of vitamin b12 malabsorption. laboratory internal quality control systems may not detect this deterioration. orgentec issued a product notification letter in which they mention a further lot - 24723945 (expiry 28/02/2014). this lot has also shown a deterioration in activity in a recent uk neqas haematinics distribution.
  • Action
    Do not use devices from the affected lot. Consider the need to review previous negative results from tests performed using the affected lot. Where results are inconsistent with the clinical picture, samples should be retested with a different lot number. It may be necessary to arrange for repeat samples. Contact Launch Diagnostics (01474 876 402) to request replacement strips for retesting. Clinical pathologists Biomedical scientists

Device

Intrinsic Factor Antibody test strips used in testing for vitamin B12 malabsorption, Alegria Anti...
  • Modèle / numéro de série
  • Description du dispositif
    Laboratory test kit: Intrinsic Factor Antibody test strips used in testing for vitamin B12 malabsorption. Alegria Anti-Intrinsic Factor Assay (ORG-247-24) lot number 24723031 expiry 30/11/2013.
  • Manufacturer
    Orgentec Diagnostika GmbH

Manufacturer

Orgentec Diagnostika GmbH