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 Randox Laboratories Ltd.

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 080 08 17 000
  • Event Initiated Date
    2017-08-21
  • Event Country
  • Event Source
    SFDA
  • Event Source URL
  • 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
    Randox has confirmed that acth in our immunoassay premium plus quality control and immunoassay premium quality control does not meet the quoted reconstituted stability claim in the product ifu. we now recommend that acth is to be assayed immediately after the 30-minute reconstitution procedure.

Device

  • Model / Serial
    Immunoassay Premium Plus Quality Controls Catalogue Number : GTIN IA3109 : 05055273207255 IA3110 : 05055273207262 IA3111 : 05055273207279 IA3112 : 05055273207286 Immunoassay Premium Quality Controls Catalogue Number : GTIN IA2638 : 05055273203844 IA2639 : 05055273203851 IA2640 : 05055273203868 IA2633 : 05055273203837
  • Product Description
    In vitro diagnostic devices
  • Manufacturer

Manufacturer