Events

Field Safety Notices about Etest® CEFOTAXIME CT 256

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 BIOMERIEUX.

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
    During a recent internal investigation of retained lots, it was observed that retained batches of the etest cefotaxime ct 256 showed failed internal qc testing. the batches were originally released with conform qc results. however, current investigations of the lots listed above show that the strips deviated from acceptable qc parameters which may result in clinical strains.

Device

Etest® CEFOTAXIME CT 256
  • Model / Serial
    1002774320 25NOV2015, 1002377890 06JUN2015, 1002590470 06SEP2015
  • Manufacturer
    BIOMERIEUX

Manufacturer

BIOMERIEUX