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 ThermoFisher Scientific.

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 001 05 12 000
  • Event Initiated Date
    2012-05-01
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=1782
  • 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
    Whole blood samples (either fresh or frozen) for hba1c testing are pre-treated with multigent hemoglobin denaturant. the pre-treated samples are placed on the architect csystems and tested for glycated hemoglobin (hba1c) and total hemoglobin (thb) concentrations. according to the package insert, pretreated samples must be allowed to incubate for a minimum of 5 minutes at 15 to 30 °c prior to testing. pretreated samples are stated to be stable for “up to 8 hours at 15 to 30 °c and up to 48 hours if stored at 2 to 8 °c”. however, recent studies have demonstrated that hba1c measurements increase with time after the samples are pre-treated. therefore, it is necessary to change the handling instructions for pre-treating samples for the multigent hba1c assay. the investigation to determine root cause is ongoing.

Device

Reagent, MULTIGENT Hemoglobin A1c Reagent
  • Model / Serial
    CATALOG NO.: 02K96-20; LOT NO.: All lots within expiry date
  • Product Description
    Used in clinical laboratories for the quantitative in vitro measurement of percent HbA1c (HbA1c fraction) in human whole blood on the ARCHITECT cSystems and the AEROSETSystem. The HbA1c assay is intended to aid in the monitoring of long-term blood glucose control and compliance in individuals with diabetes mellitus.
  • Manufacturer
    ThermoFisher Scientific

Manufacturer

ThermoFisher Scientific
  • Manufacturer Parent Company (2017)
    Thermo Fisher Scientific Inc
  • Manufacturers representative
    Ebrahim M. Al-Mana & Bros. Co. Ltd., Riyadh, (01) 4610733
  • Source
    SFDA