Events

Field Safety Notices about Mueller Hinton E Agar

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 bioMérieux SA.

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
  • 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
    Following qc failures (diameter out of range - too high) when testing atcc strains for antibiotic susceptibility test by disk diffusion method when using mhe agar reported from the field, biomérieux initiated a complaint investigation to check product performance and determine the root cause of the issue observed by a customer. it could be determined that the use of the medium mhe by disk diffusion method with the antibiotics belonging to cyclines and aminosides classes could potentially lead to failure to quality control test (out of range high) and false susceptible result for clinical isolates (whatever the strain that could be tested) instead of resistant results. the investigation states that the identified non-conformity concerns all lots manufactured using a specific formulation. as a consequence new lots produced using new formulations perform within the expected specifications and those new lots are not affected by the above issue. .

Device

Mueller Hinton E Agar

Manufacturer

bioMérieux SA