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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00084-1
Product Name/Description Automate 2550 and 1250 Aliquotter Tip Present Sensor. An in vitro diagnostic medical device (IVD)

ARTG Number: 177999
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 6/02/2018
Responsible Entity Beckman Coulter Australia Pty Ltd
Reason/Issue Beckman Coulter has identified a potential issue with the tip present sensor within the Robot of the Aliquoter module. There has been one overseas report of a misaligned sensor in an AutoMate system, which resulted in the system processing samples without pipette tips. A small number of samples were subject to cross-contamination and were sent to the error rack prior to analysis. In this particular case, the system gave no external sign of a misaligned tip present sensor.
There is no impact to the Sorter module associated with this issue.
Recall Action Product Defect Correction
Recall Action Instructions Beckman Coulter will arrange field service engineers to inspect affected devices to inspect the tip present sensor for misalignment.
If users suspect or observe unusual contamination of the tip carrier arm whilst performing daily maintenance, as described in the IFU please contact the local Beckman Coulter representative immediately. If this is to occur, it is recommended to discontinue use of the Aliquotter module.

This action has been reviewed and is considered complete in accordance with the requirements of the URPTG.
Contact Information 1800 060 881 - Beckman Coulter Customer Support Centre