Events

Alerte Ou Avis De Sécurité sur ThermoScientificTM OxoidTM CAZ10 ceftazidime, CT1629B antimicrobial susceptibility test disc

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 Oxoid Ltd.

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
  • Numéro de l'événement
    MDA/2017/034
  • Date
    2017-11-23
  • Date de publication de l'événement
    2017-11-23
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://www.gov.uk//drug-device-alerts/thermoscientifictm-oxoidtm-caz10-ceftazidime-ct1629b-antimicrobial-susceptibility-test-disc-potential-for-false-resistance-results-if-stored-at-the-wrong-temperature
  • 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
    Manufactured by oxoid ltd (thermofisher scientific) – antibiotic (ceftazidime) concentration may decrease over time if test disc is stored between 2°c and 8°c: only specific lots are affected (mda/2017/034).
  • Action
    Ensure all relevant members of staff receive the manufacturer’s Field Safety Notice (FSN) and that they understand the problem and the actions to be taken. Destroy all affected lots (listed in the FSN) and contact Thermo-Fisher customer services / local distributor for replacements. Discs that have been stored between -20°C and 2°C remain unaffected for the entire shelf life (36 months). If concerns exist after repeat testing, alternative methods of establishing ceftazidime susceptibility should be used. As part of your review processes, report any incorrect results to MHRA via Yellow Card or the relevant devolved administration.

Device

ThermoScientificTM OxoidTM CAZ10 ceftazidime, CT1629B antimicrobial susceptibility test disc
  • Modèle / numéro de série
  • Manufacturer
    Oxoid Ltd

Manufacturer

Oxoid Ltd
  • Adresse du fabricant
    Martyn Rogers Thermofisher Scientific Wade Road Basingstoke RG24 8PW Telephone: 01256 694 245martyn.rogers@thermofisher.com
  • Société-mère du fabricant (2017)
    Thermo Fisher Scientific Inc
  • Source
    MHRA