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 Diagnostica Stago.

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 056 11 18 000
  • Event Initiated Date
    2018-11-20
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13504
  • 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
    Stago has informed that several customers have reported shortened (t1-t2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds for sta-control la2 have been observed (this range is specified on the kit value sheet). the subsequent root cause investigations have found that the issue is due to a sensitivity decrease which occurs towards the end of the respective lot number's shelf life. we have found this to be related to the material used for manufacturing the stoppers used only for the buffer and solvent vials. according to guidelines of the isth ssc anti phospholipids syndrome, several tests should be performed to detect and confirm the presence of la. hence, previously released patient results should not need to be re-assessed. there have been no reports of injury in relation to this issue.

Device

STACLOT LA (REF. 00600).
  • Model / Serial
    Lot Number: 251918 Expiry: 31 March 2019 Lot Number: 252751 Expiry: 30 September 2019
  • Product Description
    An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Diagnostica Stago

Manufacturer

Diagnostica Stago
  • Manufacturer Parent Company (2017)
    Stago International
  • Manufacturers representative
    Medical supplies & Services Co.Ltd Mediserv
  • Source
    SFDA