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 Sekisui Diagnostics.

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 094 06 12 000
  • Event Initiated Date
    2012-06-18
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=1952
  • 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
    Discoloration of the acetaminophen enzyme reagent (rl) has been observed in some cartridges of lot 41928uq11. the discolored reagent generates a high calibration factor and erratic control recovery. product tested during the investigation showed quality control results outside of expected ranges (> 3sd, both low and high).

Device

IVD, MULTIGENT Acetaminophen Reagent
  • Model / Serial
    Cat. No. 2K99-20. Lot Number: 41928UQ11 Expiration Date: January 31,2013
  • Product Description
    IVD, Reagent, Test
  • Manufacturer
    Sekisui Diagnostics

Manufacturer

Sekisui Diagnostics
  • Manufacturer Parent Company (2017)
    Sekisui Chemical Co. Ltd.
  • Manufacturers representative
    Medical supplies & Services Co.Ltd Mediserv, Riyadh, (01) 4780555
  • Source
    SFDA