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 Roche 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 009 12 18 000
  • Event Initiated Date
    2018-12-05
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13563
  • 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
    In readiness for the introduction of a new analyzer, selected endogenous drug interferences in serum/plasma, urine and csf (cerebrospinal fluid) were assessed for their potential risk on all roche tests and corresponding platforms. the root cause for the interference is the direct concentration-dependent interaction of the interferent with the test system. new endogenous interference claims for three tests with potential medical risk were found: bil-t gen.3, igm gen2 (igmp2 sensitive application) in serum/plasma & lact gen.2 in csf. please read the attached fsn.

Device

cobas c 311/501/502/701/702
  • Model / Serial
    Product code: 05795397190, 05795419190, 03183700190, 05171881190, 03507190190 & 05220726190
  • Product Description
    In vitro diagnostic device
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics
  • Manufacturer Parent Company (2017)
    Roche Holding AG
  • Manufacturers representative
    FAROUK, MAAMOUN TAMER & COMPANY
  • Source
    SFDA