Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2017-RN-01404-1
Product Name/Description Remisol Advance Software Versions 1.6-1.9, Architect Driver

ARTG Number: 296020
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 16/11/2017
Responsible Entity Beckman Coulter Australia Pty Ltd
Reason/Issue 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.
Recall Action Recall for Product Correction
Recall Action Instructions 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;
(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.

This action has been closed out on 12/07/2019
Contact Information 1800 060 881 - Beckman Coulter Customer Support Centre