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 BD.

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 078 10 18 001
  • Event Initiated Date
    2018-11-06
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13453
  • 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 , FDA
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    Bd has confirmed that a limited number of bd max™ systems were manufactured with purchased optical filters that have shown a potential to produce a false positive result for candida glabrata when processing samples positive for trichomonas vaginalis during testing with the bd max™ vaginal panel. if the bd max vaginal panel was successfully verified/validated using the contrived zeptometrix vaginal panel control panel, the risk of reporting a clinical false positive c.Glabrata result is low. the reported c. glabrata false positive results were all identified by customers when using the control material.

Device

BD MAX System
  • Model / Serial
    Catalog No.: 441916 Multiple serial numbers of the affected device are provided in the attached FSN. ................................................................. FDA update codes: BD Max Instrument, Catalog Number 441916 441927 Serial Numbers: CTI1201-CTI1288 Catalog Number 8090369/443364, 44336409 Serial Numbers: 079577 to 079896, 78154, 78503, 78363, 78321, 78584, 78840, 78975, 78711, 77048, 79783, 78857, 79162, 78387, 78182, 78832, 78905, 77062, 78856, 78352, 78903, 78667, 78665, 78928, 78986, 77108, 77543, 78615, 78481, 77373, 77707, 78927
  • Product Description
    IVD Test Reagent/Kits
  • Manufacturer
    BD

Manufacturer

BD