Events

Field Safety Notices about Vials lD-DiaCe/l I, lD-DiaCell II, ID-Diacell III only

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 Bio-Rad.

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
    2017-02-10
  • 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
    We would like to share with you, and your team, information about unexpected reactions primarily on eluates and qc samples but also with some patient samples when using the above mentioned products. this phenomenon is observed randomly between batches, and also within single batches.

Device

Vials lD-DiaCe/l I, lD-DiaCell II, ID-Diacell III only
  • Model / Serial
    lD-Dia (Diego) Positive 004134 |D~DiaCel| SF 003640 lD-DiaCell Pool 003630 / 003631 lD—DiaCellABO/l 1* 003610 lD-DiaCellABO/l l—lll * 003618 lD-DiaScreen | —| V-VP-VIP 004316 lD—DiaCell || 003613 lD- Panel 004114 lD-DiaCell I— 004310 All lots currently in date lD-DiaScreen 004311 iD-DiaCell l-ll || Asia 003614 lD- iaScreen Prophylax 004330 'aPanel Plus 6 004414 003613VJ lD-DiaPanel (1—11) 004114VJ ID-Dia Pos' iv 004134VJ 004310VJ
  • Manufacturer
    Bio-Rad

Manufacturer

Bio-Rad