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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-01101-1
Product Name/Description AQUIOS CL Flow Cytometry System. An in vitro diagnostic medical device (IVD)

Part Number: B30166

ARTG Number: 177999
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 23/08/2017
Responsible Entity Beckman Coulter Australia Pty Ltd
Reason/Issue As a result of internal investigations, Beckman Coulter has learned that an erroneous configuration setting during servicing may be possible on the AQUIOS CL instruments. If the incorrect configuration occurs, the probe may aspirate samples only from a single tube and will not aspirate samples from the remaining tubes in the cassette.

The probe would repeatedly aspirate from a single tube position in the cassette, resulting in erroneous patient results for the remaining tubes in the cassette. This causes a mismatch between the test result given and the sample ID.
Recall Action Recall for Product Correction
Recall Action Instructions 1. Quality Control samples must be run utilising the control cassette and the autoloader. The controls will not pass if this issue exists on the unit, when run using the autoloader. If the controls do not pass, immediately contact a Beckman Coulter representative.
2. BEC Service organisation will be in contact to ensure that the configuration settings are correct.

This action has been closed out on 05/07/2019
Contact Information 1800 060 881 - Beckman Coulter Customer Support Centre