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 Immucor 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
    Recall / Field Safety Notice
  • Event ID
    mdprc 071 03 17 000
  • Event Initiated Date
    2017-03-19
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=10806
  • 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: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    Immucor is issuing this product notification regarding the v antigen typing for donor d1741, cell #4 on capture-r ready-id, lots 1d324 and id325. further dna testing of donor d1741 has confirmed the donor as v—, instead of v+ as indicated on the master list.

Device

Capture-R Ready-ID
  • Model / Serial
    Lot Nos. : ID324 and ID325 Ref: 0066204 and 0066214 UDI: - 0066204: 10888234001140 - 066214: 108882340011 88
  • Product Description
    Reagents, Immunohematology, Antibody Detection/Identification, Antiglobulin
  • Manufacturer
    Immucor GmbH

Manufacturer

Immucor GmbH
  • Manufacturer Parent Company (2017)
    Ivd Holdings Inc
  • Manufacturers representative
    Medical supplies & Services Co.Ltd Mediserv
  • Source
    SFDA