Events

Safety Alert Or Field Safety Notices for OrthoBioVue multi-reagent cassettes

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 Ortho Clinical Diagnostics.

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/2013/058
  • Event Number
    CON297526
  • Date
    2013-07-26
  • Event Date Posted
    2013-07-26
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON297526?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
    A small number of multi-reagent cassettes in affected lots have been found with labels containing product information on the wrong side of the cassette. the use of affected multi-reagent cassettes may lead to false negative or false positive results, causing a potential misclassification of the patient or donor blood groups or rh/k phenotypes or incorrect antibody detection results.  this may be of particular clinical concern where there is no confirmation of the group (e.G. in testing of newborns or where reverse grouping is not in place). ortho clinical diagnostics have sent out a field safety notice having identified the cause of the manufacturing issue.
  • Action
    Do not use and quarantine products from affected lots received prior to 5 July 2013.  Contact the manufacturer urgently for replacement product. Products from affected lots received prior to 5 July 2013 should be used only where no alternative stock is available and must be inspected prior to use (see manufacturer’s Field Safety Notice). Discard products from affected lots received prior to 5 July 2013 once replacement stock is available for use. Consider the need to review patient results from the affected lots. As part of your look back process, report any incorrect results to the MHRA and Ortho Clinical Diagnostics. Directors of pathology Lead clinical scientists (haematology) Lead biomedical scientists (haematology and blood transfusion) Clinical services managers Laboratory managers

Device

OrthoBioVue multi-reagent cassettes
  • Model / Serial
  • Product Description
    Blood grouping cassettes. OrthoBioVue multi-reagent cassettes. See the manufacturer’s Field Safety Notice for a list of affected products and lot numbers. Products received by you after 5 July 2013 were inspected by the manufacturer prior to shipping. NOTE: There is no risk associated with the use of an affected single-reagent cassette since all wells contain the same reagent.
  • Manufacturer
    Ortho Clinical Diagnostics

Manufacturer

Ortho Clinical Diagnostics