Events

Safety Alert Or Field Safety Notices for Biokit Best 2000 laboratory analyser used in combination with the BioMerieux Vironostika HIV Uni-Form II Ag/Ab assay

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 N/A.

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/2005/036
  • Event Number
    CON1004063
  • Date
    2005-06-23
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON1004063
  • 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
    False results may be observed when using this combination of assay and laboratory analyser. this combination has not been validated by either manufacturer. the mhra has received a report from a laboratory of an unrepeatable positive hiv test result. the positive result was not confirmed when further routine testing was carried out. the result was generated using a biokit best 2000 laboratory analyser in combination with the biomerieux vironostika hiv uni-form ii ag/ab assay. the cause of the false result has not been determined. however, biokit has stated that they have not validated this test for use on the analyser and they cannot guarantee the accuracy, reproducibility or performance of this combination. biomerieux has stated that although the analyser meets the specifications set out in their instructions for use, this combination of assay and laboratory analyser has not been validated by them.
  • Action
    Do not use this (or any other) combination of assay and laboratory analyser unless you have verified that the combination of assay and laboratory analyser has been properly validated for safety, quality and performance. ACTION DEADLINES FOR THE SAFETY ALERT BROADCAST SYSTEM (SABS) Trust managers should ensure that measures to implement the 'Actions' specified above are planned and completed in line with the following SABS deadlines. Further information about SABS can be found at: www.info.doh.gov.uk/sar/cmopatie.nsf

Device

Biokit Best 2000 laboratory analyser used in combination with the BioMerieux Vironostika HIV Uni-...
  • Model / Serial
  • Product Description
    Biokit Best 2000 laboratory analyser used in combination with the BioMerieux Vironostika HIV Uni-Form II Ag/Ab assay. The Biokit Best 2000 is also on the market as the Dynex Technologies DSX laboratory analyser. PROBLEM: The MHRA has received a report from a laboratory of an unrepeatable positive HIV test result. The positive result was not confirmed when further routine testing was carried out. The result was generated using a Biokit Best 2000 laboratory analyser in combination with the BioMerieux Vironostika HIV Uni-Form II Ag/Ab assay. The cause of the false result has not been determined. However, Biokit has stated that they have not validated this test for use on the analyser and they cannot guarantee the accuracy, reproducibility or performance of this combination. BioMerieux has stated that although the analyser meets the specifications set out in their instructions for use, this combination of assay and laboratory analyser has not been validated by them. ACTION:
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    MHRA