Events

Recall of Remisol Advance

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Normand Informatique.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    78394
  • Event Risk Class
    Class 2
  • Event Number
    Z-0235-2018
  • Event Initiated Date
    2017-10-16
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159406
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Calculator/data processing module, for clinical use - Product Code JQP
  • Reason
    Beckman coulter has identified that due to a software nonconformity in connection with a changed service setting remisol could display wrong results.
  • Action
    Beckman Coulter sent an Urgent Medical Device Recall letter dated October 16, 2017, to all affected customers. Beckman Coulter has identified a potential issue due to a software nonconformity which could occur after a default service setting (NoCondition) is manually changed from off to on, potentially causing results outside of analytical range to be erroneously displayed. For further questions, please call (800) 526-3821.

Device

Remisol Advance
  • Model / Serial
    Version 1.6-1.9
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution and to the countries of : Australia, France, Germany, Israel and Russia
  • Product Description
    Remisol Advance Software (Driver Architect) Catalog Number B32129 || The Remisol Advance Data Manager (Stand alone Data Management Systems) collects and manages data and manages workflows for connected systems. (i.e. Beckman Coulter Instruments, Automations, LIS &). It provides data analysis capabilities such as automatic results validation, delta checking, reflex testing, quality control, results editing and data management (i.e. archiving and restoration of patient results). The Remisol Advance system also offers workstation consolidation to three Beckman Coulter instruments from a single user console.
  • Manufacturer
    Normand Informatique

Manufacturer

Normand Informatique
  • Manufacturer Address
    Normand Informatique, Normand Informatique, Sci Git; 57 Grand place; Cs 10451, Arras CEDEX France
  • Source
    USFDA