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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-00748-1
Product Name/Description Recapper for the AutoMate 2500 Family. An in vitro diagnostic medical device (IVD).

ODL25250 AutoMate 2500

ARTG Number: 177999
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 27/06/2017
Responsible Entity Beckman Coulter Australia Pty Ltd
Reason/Issue Beckman Coulter has identified there is a potential that a component on the recapper Module did not have the required coating specified for that part.
The coating on the recapper component helps to ensure both the longevity of the part, and help the gripper to release the parafilm so it properly seals to the tube.
If there is an uncoated component on your recapper, this could lead to the tubes not being properly sealed. In the worst case scenario, this could cause sample cross contamination and subsequent misdiagnosis.
Recall Action Recall for Product Correction
Recall Action Instructions Beckman Coulter will schedule a time to visit affected users to confirm whether the proper coating on the recapper component is present, and replace the component. In the interim, users are advised that no action is required on their part.

This action has been closed out on 01/11/2018
Contact Information 1800 060 881 - Beckman Coulter Customer Support Centre