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 BioMerieux Inc..

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 028 07 18 000
  • Event Initiated Date
    2018-07-05
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12860
  • 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
    The bact/alert® virtuo® instrument firmware version r2.0 allows relocation of the four (4) resident calibration standards so that field system engineers (fse) can service the associated cells p24 - p27, where the calibration standards typically reside. if the calibration standards are not returned to the designated locations, an anomaly may occur. following a reboot via the instrument’s small user interface screen, while patient or test bottles are loaded in cells p24 - p27, the following will occur: 1. the unload date/time will be set to the current date/time, causing the bottle status to be set to “unload” even though the bottle remains in the instrument. 2. the bottle will continue to process; however, in the event of a positive bottle in cells p24 – p27, no indication of a positive bottle will be observed by the user. neither the visual (flashing yellow light) nor audible alarm will occur. 3. although the instrument does not provide alarm to the user, the bottle result (positive or negative) is transferred to the lis (laboratory information system). two consecutive error conditions may also be observed for bottles in cells p24 – p27: 1. an “anonymous bottle” alarm. 2. a “duplicate bottle” alarm. to prevent this anomaly from occurring, your local field service engineer (fse) has confirmed the calibration standards are in the designated bottle cell locations.

Device

BACT/ALERT® VIRTUO® Microbial Detection System
  • Model / Serial
    Reference: 411660, 411661, 419947 All serial numbers are impacted
  • Product Description
    Analyzers, Laboratory, Microbiology, Blood Culture, Automated
  • Manufacturer
    BioMerieux Inc.

Manufacturer

BioMerieux Inc.