Events

Field Safety Notices about PANOCELL-20

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 Immucor Medizinische Diagnostik GmbH.

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
    This communication is to inform you of reports that immucor has received concerning unexpected positive reactivity when testing donor n3512 with anti-v. our initial investigation into these reports has confirmed that donor n3512 is v+ when tested with additional sources of anti-v. donor n3512 will be labeled as v+ going forward. .

Device

PANOCELL-20
  • Model / Serial
    Capture-R® Ready-ID® ID286 11 2016-03-22 Capture-R® Ready-ID® ID287 12 2016-03-22 Panocell-20® 47436 18 2016-01-29 Panocell-16® 39330 16 2015-12-04 Panocell-20® 23160 16 2015-08-14 Panocell-20® 14052 18 2015-06-12 Capture-R® Ready-ID® Extend II DN074 13 2014-07-29
  • Manufacturer
    Immucor Medizinische Diagnostik GmbH

Manufacturer

Immucor Medizinische Diagnostik GmbH