Events

Field Safety Notices about HLA A typing kits

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 Olerup SSP.

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
    2016-05-04
  • 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
    The false negative amplification for the a*01 kit yields a revised reactivity pattern for the a*01:04n allele that is identical to a*01:01 alleles. the false negative amplification in the kit a*24 add-on creates a kit that cannot separate the a*24:11n from the a*24:02:olg alleles“.

Device

HLA A typing kits
  • Model / Serial
    A*01 Lots: 41V, 35X, 83Y A*24 Add-on Lot 32Y
  • Manufacturer
    Olerup SSP

Manufacturer

Olerup SSP