Events

Recall of Remisol Advance Software Versions 1.6-1.9, Architect Driver

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Beckman Coulter Australia Pty Ltd.

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
    RC-2017-RN-01404-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-11-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01404-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    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. please note that the “nocondition” setting is not customer configurable through any instructions, but is reserved for field service configuration. if both conditions occur at the same time, i.E. the changed setting and a result outside of analytical range, an incorrect result could potentially be reported to the physician.
  • Action
    Beckman Coutler is advising users to check device settings as directed in the letter supplied to customers. If the setting is correct there is no further action required. If the setting is NOT correct, users should contact their local Beckman Coulter representative immediately, and either: (1) discontinue use of Remisol with the Architect instrument; or (2) monitor results sent from the Architect instrument to Remisol to ensure Remisol does not receive results outside the dynamic range from the Architect instrument.

Device

Remisol Advance Software Versions 1.6-1.9, Architect Driver

Manufacturer

Beckman Coulter Australia Pty Ltd