Events

Field Safety Notices about VITEK® 2 Gram-Positive (GP)

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.

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
    2017-10-17
  • 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
    Users of the aforementioned test reported atypically negative results for enterococcus casseliflavus atcc® 700327 ™, and the biomerieux manufacturer conducted an internal investigation to confirm that quality control (qc) for the vitek 2 gp id card did indeed produce a negative result for the table in the indicated lot. according to the instruction of vitek 2 gp id, the expected reaction for the o129r strain atcc 700327 is positive. your lab did not receive any of the lots listed below, but the biomerieux manufacturer has taken action and includes, in the scope of this notice, all batches of vitek 2 gp id cards made with the same raw materials as the lots listed below (see appendix b for a full list).

Device

VITEK® 2 Gram-Positive (GP)

Manufacturer

bioMérieux