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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-00820-1
Product Name/Description	Coulter LH and HmX Analysers. An in vitro diagnostic medical device (IVD) Coulter LH 750 Analyser Reference Numbers: 6605632, A85570, A68807 Coulter LH 780 Analyser Reference No: 723585, A90728, A68808 Coulter LH 500 Analyser Reference No: 178832, 178833, 178834, A91062, A90994 Coulter HmX CP Analysers Reference No: 6605522, 6605523, 6605524 Coulter HmX AL Analysers Reference No: 6605525, 6605526, 6605527, A85566, A85564 All software versions ARTG Number: 177999
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	27/06/2017
Responsible Entity	Beckman Coulter Australia Pty Ltd
Reason/Issue	Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the LH 750, LH 780, LH 500 and HmX Analysers may not flag or detect blasts in some blood samples. This is due to limitations in the available technology as well as the properties of blasts in certain samples. If these limitations are not clearly understood or are misinterpreted, in rare situations there could be a delay in the recognition, diagnosis and treatment of conditions associated with blasts in the peripheral blood.
Recall Action	Recall for Product Correction
Recall Action Instructions	Users are asked to refer to the modified information for both the Suspect messages and Limitations sections for the Differential as contained in the Customer Letter. This action has been closed out on 19/10/2018
Contact Information	1800 060 881 - Beckman Coulter Technical Support Centre