Events

Safety Alert Or Field Safety Notices for BD Vacutainer® EDTA & BD Vacutainer® Lithium Heparin Tubes

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 Becton Dickinson.

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
  • Date
    2018-04-26
  • Event Date Posted
    2018-04-26
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/bd-vacutainer-edta-bd-vacutainer-lithium-heparin-tubes-risk-of-incorrect-results-for-lead-testing-or-other-assays-using-asv-methodology
  • 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
    BD have published a Field Safety Notice to advise users to discontinue lead testing with affected devices when using assays with ASV methodology, known to be used within the Magellan LeadCare® testing systems, or any other assay employing ASV methodology.BD have identified that Thiuram, a chemical in the rubber tube stopper may release sulfur gases which bind to the lead particles in the blood sample making it difficult to detect the correct amount of lead in the sample and may give false low results when using ASV methodology, used in Magellan Diagnostics’ LeadCare® Testing Systems, and other assays.BD have undertaken a programme of testing to identify if any other assays are affected by the issue identified. To date no other assays have been noted to be affected. Revised instructions for use will be made available for users to download by the 8th May 2018.
  • Reason
    Manufactured by becton dickinson (bd) – due to a material in the rubber stopper, affected blood collection tubes may not be compatible with assays using anodic stripping voltammetry (asv) methodology.
  • Action
    Identify affected devices, which are listed in the manufacturer’s Field Safety Notice (FSN). Discontinue lead testing with affected devices when using assays with ASV methodology, known to be used within the Magellan LeadCare® testing systems, or any other assay employing ASV methodology. There is no requirement for customers to return affected devices to BD. Review previous lead test results which were performed using Magellan LeadCare® instrumentation or any other assay employing ASV methodology. Lead testing using Graphite furnace atomic absorption spectroscopy (GFAAS) coupled with ICP-MS are not affected by this issue and can be performed as normal with BD Vacutainer® EDTA and BD Vacutainer® Lithium Heparin tubes. If any adverse events occur relating to these products, please report these to MHRA via YellowCard or the relevant devolved administrations (Scotland, Wales and Northern Ireland).

Device

BD Vacutainer® EDTA & BD Vacutainer® Lithium Heparin Tubes
  • Model / Serial
  • Product Description
    Becton Dickinson: BD Vacutainer® EDTA & BD Vacutainer® Lithium Heparin Tubes
  • Manufacturer
    Becton Dickinson

Manufacturer

Becton Dickinson