Events

Field Safety Notices about ETEST® OX 256 (OXACILLIN) Foam packaging

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
    Based on qc failures (mic out of range high) for s.Aureus atcc 29213 strain on etest® ox 256 (oxacillin) foam packaging (ref. 520558, 520518) reported from the field, biomérieux initiated a complaint investigation to confirm product issue and determine root cause. .

Device

ETEST® OX 256 (OXACILLIN) Foam packaging
  • Model / Serial
    520518 ETEST®OXACILLIN OX 256 WW F100 520518 1003055340 01-Apr-2017 1003315740 28-Jul-2017 1004070580 08-Jun-2018 1004319590 22-Sep-2018 1004818850 21-Apr-2019 1004890270 24-May-2019 1005366110 12-Dec-2019 520558 ETEST®OXACILLIN OX 256 US F100 1003059010 01-Apr-2017 1003315830 28-Jul-2017 1004071250 08-Jun-2018 1004818860 21-Apr-2019 1004890400 24-May-2019
  • Manufacturer
    bioMérieux SA

Manufacturer

bioMérieux SA