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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-00159-1
Product Name/Description Lysercell WDF 2 x 4L used on Sysmex XN-Series Automated Haematology Analysers. An in vitro diagnostic medical device (IVD).

Material Number: 06510221001

Lot Numbers: A6028, A6029, A6030

ARTG Number: 188498
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 1/02/2017
Responsible Entity Roche Diagnostics Australia Pty Limited
Reason/Issue Roche Diagnostics Australia has received several reports that Lysercell WDF 2 x 4L lots A6028, A6029 and A6030 can lead to an increased occurrence (up to 3-fold) of the flag “Blast/Abn Lympho?” . No other flags have been observed. This issue leads to an increase in the “Blast/Abn Lympho?” flagging rate and unnecessary manual review. The risk of a misdiagnosis is mitigated by the fact that any flags observed from the affected instruments must be confirmed by a qualified morphologist using a manual blood film.
Recall Action Recall
Recall Action Instructions Roche is advising customers to immediately discontinue use of and quarantine affected lots. New replacement lots will be provided by Roche.
This action has been closed-out on 21/03/2018.
Contact Information 02 9860 2357 - Roche Diagnostics Australia