Events

Safety Alert Or Field Safety Notices for Laboratory reagents requiring manual handling for use in combination with cobas c 502 analyser

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 Roche.

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/2014/012
  • Event Number
    CON406356
  • Date
    2014-04-16
  • Event Date Posted
    2014-04-16
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON406356?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
    The level sensing function of the cobas c502 laboratory analyser has not been activated for tests requiring manual reagent handling. the use of insufficient volumes of reagent may lead to a false negative result and a missed diagnosis, such as syphilis. it is possible to obtain ‘valid’ but inaccurate results when there is no reagent remaining in the roche cassette. since we issued a notice in february 2012 (mda/2012/004) the settings for level sensing have not been correctly encoded in some rec files, therefore level sensing may not have been correctly performed on cobas c502 analysers.
  • Action
    Follow the required actions set out in the manufacturer’s Field Safety Notice (FSN). If you have used the affected combination of devices, consider the need to review previous results and whether to recall and retest patients. Action by: Laboratory managers Directors of pathology GUM clinics.

Device

Laboratory reagents requiring manual handling for use in combination with cobas c 502 analyser
  • Model / Serial
  • Product Description
    Laboratory reagents requiring manual handling for use in combination with cobas c 502 analyser made by Hitachi, supplied by Roche. Multiple tests are affected, including syphilis (TPLA) test made by Sekisui. All reagents are supplied by Roche. The analyser can run assays that are: manufactured by Roche manufactured by third parties and supplied by Roche – ‘partnership assays’ (eg TPLA) Affected assays include those requiring manual handling that are listed in the Roche Field Safety Notice
  • Manufacturer
    Roche

Manufacturer

Roche