Events

Field Safety Notices about ID-DiaCell

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 Laboratories.

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
    2017-09-27
  • 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 have been made aware that the above-mentioned products of cells may show antibody of (antibody undetermined specificity) undetermined specificity (aus) in iat method which are not confirmed by further testing's. the company is fully aware of the magnitude of this problem and the level of distress that this is causing in the field. a risk assessment has been performed and no patient risk has been identified. a team of experts is currently working on this issue äs an absolute priority. we will let you know about any updates of this issue.

Device

ID-DiaCell
  • Model / Serial
    ID-DiaCell 1-11-111 ID-DiaCell A1A2B/I-II-III ID-DiaCell 1-11 ID-DiaCell 1-11-111 Asia ID-DiaPanel ID-DiaPanel 6 Plus Cat. ref. n° 004310 003618 003613 003614 004114 004414
  • Manufacturer
    Bio-Rad Laboratories

Manufacturer

Bio-Rad Laboratories