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.

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 149 12 12 000
  • Event Initiated Date
    2012-12-24
  • 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
    Cobas® taqman® mtb test definition files (tdf) v3.0, for both ce-ivd and jpn-ivd tests, have an incorrect target elbow max cutoff value of 48. the correct target elbow max cutoff value should be 50. the tdfs are used with the cobas® taqman® mtb test and amplilink software v. 3.3 series.

Device

  • Model / Serial
    The affected TDFs are: SET CD-ROM CTM48 MTB QUAL v1 TDF v3.0 CE-IVD M/N 05574455190 SET CD-ROM CTM48 MTB QUAL v1 TDF v3.0 JPN-IVD M/N 05574447190
  • Product Description
    IVD, Test
  • Manufacturer

Manufacturer

  • Manufacturer Parent Company (2017)
  • Manufacturers representative
    FAROUK, MAAMOUN TAMER & COMPANY, Riyadh (01) 4142200
  • Source
    SFDA