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 089 10 11 000
  • Event Initiated Date
    2011-10-30
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=968
  • 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
    Incidents have been reported to hemocue ab in which the hemocue glucose 201+ system with software version 106 and lower has showed 0.0 mmol/l (0 mg/dl) instead of indicating that the blood glucose result was high and outside the measuring range of the system. the problem is related to a known software bug in the hemocue glucose 201+ analyzers manufactured before 2006.

Device

Analyser, blood glucose, HemoCue Glucose 201+ system
  • Model / Serial
    HemoCue Glucose 201+ system, Model no.: 120710, 120711, 120712, 120713, 120714, 120715, 120716, 120717, 120718, 120719, 120721, 120722, 120723-R, 120751, 120752 Software version: 106 and lower
  • Product Description
    Analyser, Blood, Glucose
  • 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