Events

Field Safety Notices about Kleihauer kit fixing reagent and elution reagent

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
  • Date
    2016-12-09
  • 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 reports are of inconsistent staining of cells and false positives reactivity with negative control samples. the reports indicate the stain is not sufficiently removed from the adult cells during the elution step; therefore it is difficult to distinguish fetal cells from the adult cells. a false positive reaction with the negative control invalidates the test results and a repeat of the test is needed. such repeat of testing may lead to delay in analysis of patient results and ultimately delay in patient treatment. .

Device

Kleihauer kit fixing reagent and elution reagent

Manufacturer

IMMUCOR Medizinische Diagnostik GmbH