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 GmbH.

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 012 01 18 000
  • Event Initiated Date
    2018-01-02
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11972
  • 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
    Dispenser issues with hematoxylin ii and horseradish peroxidase reagents.

Device

Hematoxylin II and Horseradish Peroxidase reagents
  • Model / Serial
    Product Name : GMMI OptiView DAB IHC Detection Kit : 06396500001 ultraView DAB IHC Detection Kit : 05269806001 iView DAB IHC Detection Kit : 05266157001 ultraView SISH Detection Kit : 05271967001 ultraView SISH DNP Detection Kit US : 05572037001 CINtec PLUS Cytology Kit (CE-IVD) : 06889565001 CINtec PLUS Cytology Kit (Canada/Japan): 06889549001 OptiView Amplification Kit : 06396518001 OptiView Amplification Kit (250 Test) : 06718663001 Hematoxylin II : 05277965001 ultraView SISH DNP Detection Kit : 05907136001 EXES VEN IVIEW DAB DET KT JPN-US EXPORT : 05266084001 CINtec PLUS Cytology Kit (US-Export : 06889549001 Multiple Lot numbers of the affected products are provided in attached FSN.
  • Product Classification
    Hematology and Pathology Devices
  • Product Description
    IVD, Reagents
  • Manufacturer
    Roche Diagnostics GmbH

Manufacturer

Roche Diagnostics GmbH
  • Manufacturer Parent Company (2017)
    Roche Holding AG
  • Manufacturers representative
    FAROUK, MAAMOUN TAMER & COMPANY, Riyadh, (011) 4142200
  • Source
    SFDA