Events

Field Safety Notices about Mueller-Hinton broth

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Remel Inc., part of Thermo Fisher Scientific.

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
    Field Safety Notice
  • Date
    2015-08-11
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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