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 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 041 11 16 000
  • Event Initiated Date
    2016-11-06
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=10190
  • 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
    The device has low calibration absorbance with ck-nac ck8313 batch 371404. the reagent does not meet specific performance characteristics quoted on the kit insert. internal testing indicates a high level of imprecision at ck-nac concentration across the reportable range. quality control results will show variabiity but maybe within the range. linearity is reduced by approximately 40% at ck-nac concentration approaching the upper end of the reportable range 2379u/l.

Device

CK Nac
  • Model / Serial
    Assay: CK Nac Catalogue Number: CK8313 GTIN: 05055273208535 Batch / Lot number: 371403
  • Product Description
    In Vitro Diagnostic
  • Manufacturer
    Randox Laboratories Ltd.

Manufacturer

Randox Laboratories Ltd.