Events

Field Safety Notices about DiaMed Q.C. System

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
    2017-09-06
  • 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 samples of the product diamed q.C. system, ihd lot n° 45950 46 1 and 45950 47 1 show excessive hemolysis in samples 1 and 4 and weakly in sample 2. a risk assessment has been performed and no patient risk has been identified. you may continue to use the hemolysed cells äs lang äs they give the expected results and we kindly ask you to scrap all remaining kits of these above mentioned lots äs soon äs you get the replacement lots. tests have been performed internally and we can confirm that currently a clear result is returned with manual testing and on the saxo- swing, ih-1000 with the hemolysed qc samples. with ih-500 we may observe uninterpretable results on reverse grouping. in this case, please use another sample to perform the reverse grouping. note: tests involving serum 1 and serum 2 are in no way affected.

Device

DiaMed Q.C. System
  • Model / Serial
    Mat. n° 45950 Lot No IHD 45950 46 1 45950471 Lot No SAP 166035461 172383471 Expiry Date 25.09.2017 09.10.2017
  • Manufacturer
    Bio-Rad

Manufacturer

Bio-Rad