Events

translation missing: en.activerecord.attributes.event.titles.recall_field_safety_notice

According to Saudi Food & Drug Authority, this translation missing: en.activerecord.attributes.event.types.recall_field_safety_notice involved a device in Saudi Arabia that was produced by Medion Grifols Diagnostics AG.

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
    Recall / Field Safety Notice
  • Event ID
    mdprc 078 12 11 000
  • Event Initiated Date
    2011-12-20
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=1181
  • Notes / Alerts
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Extra notes in the data
    Report Source: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    Identified that cell #5 (donor m2683cg) of the affected products was supposedly wrongly identified as fyb negative. at release time medion's qc testings showed negative reactions with several anti-fyb reagents. additional testing performed later at medion, however, revealed that the serological reactivity from this donor varied from weak positive results to negative results depending on the commercial anti-fyb reagent used. the probable phenotype was fya/fyb weak (also known as fyx).

Device

Antibody identification cell panel kit
  • Model / Serial
    Ref. 213587: 610011010 (exp. 2011-11-12); Ref. 213392: 612011010 (exp. 2011-11-12); Ref. 213641: 612011010 (exp. 2011-11-12)
  • Product Description
    Data-Cyte Plus 0.8%, Data-Cyte Plus 3% ,Data-Cyte Plus 3% US
  • Manufacturer
    Medion Grifols Diagnostics AG

Manufacturer

Medion Grifols Diagnostics AG