Events

Safety Alert Or Field Safety Notices for Intrinsic Factor Antibody test strips used in testing for vitamin B12 malabsorption, Alegria Anti-Intrinsic Factor Assay (ORG-247-24)

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Orgentec Diagnostika GmbH.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2013/041
  • Event Number
    CON286935
  • Date
    2013-06-19
  • Event Date Posted
    2013-06-19
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON286935?tabName=allTabs
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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...
  • Model / Serial
  • Product Description
    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