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 Radiometer Medical.

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 040 11 12 001
  • Event Initiated Date
    2014-01-30
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=5208
  • 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
    Radiometer recently became aware that some membranes may have enzyme residues on the outer membrane. upon replacement of the lactate membrane the enzyme residue may cause an initial negative bias on the reported lactate result. the bias decreases over the in-use time, and depending on the amount of residue it may take anything between hours and days for the bias to disappear. worst case the bias upon membrane replacement is -1.5 mmol/l at lactate levels over 7.0 mmol/l. this is most apparent when comparing results measured before and immediately after membrane replacement.

Device

Lactate membrane units
  • Model / Serial
    The membrane units affected are: All lots of 942-066 When used on:ABL700 Series, and ABL800 Analyzers.
  • Product Description
    measuring, Lactate, membrane, Analyzers
  • Manufacturer
    Radiometer Medical

Manufacturer

Radiometer Medical
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Manufacturers representative
    Salehiya Trading Est., Riyadh, (01) 2628939
  • Source
    SFDA