Events

Avis De Sécurité sur Mueller-Hinton broth

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Remel Inc., part of Thermo Fisher Scientific.

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
    Field Safety Notice
  • Date
    2015-08-11
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    A customer complaint triggered a technical investigation which confirmed that specific lots of t3462 broth, could produce out of specification high quality control results for the antibiotic tigecycline with the quality control organism enterococcus faecalis. further investigations identified that a different style of cap was used during the manufacture of a number of lots which could affect the seal on the vial and potentially result in oxygenation of the broth. the cap was also used for defined lots of cp11410 and cp112-10. therefore, all products that used the same cap and that could be used in conjunction with tigecycline, are being recalled. .

Device

Mueller-Hinton broth

Manufacturer

Remel Inc., part of Thermo Fisher Scientific