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 HemoCue A B.

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 027 12 14 000
  • Event Initiated Date
    2014-12-02
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=6820
  • 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
    The manufacturer hemocue ab has become aware of that parts of lot 1407345 of the hemocue glucose 201 microcuvette have been produced without enzymes in the reagent. due to lack of enzymes, no reaction will take place in the microcuvette when filled with whole blood.

Device

HemoCue Glucose 201 Microcuvettes
  • Model / Serial
    Model: 110716 Lot/batch no.: 1407345
  • Product Description
    IVD, Glucose measurements
  • Manufacturer
    HemoCue A B

Manufacturer

HemoCue A B
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Manufacturers representative
    Raez Environmental System & Advanced Technologies, Riyadh, (01) 4782295
  • Source
    SFDA