Events

Alerte Ou Avis De Sécurité sur Laboratory reagents requiring manual handling for use in combination with cobas c 502 analyser

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Roche.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • ID de l'événement
    MDA/2014/012
  • Numéro de l'événement
    CON406356
  • Date
    2014-04-16
  • Date de publication de l'événement
    2014-04-16
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON406356?tabName=allTabs
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
  • Description du dispositif
    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