Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:21975
Brand Name:Lysercell WDF
Model:
Affected:Affected Lots: A6027, A6028, A6029, A6030, A6031, A6032, A6033, A6034, A6035, A6037, A6039, A7001, A7002, A7004
Software version:
Recalling Organisation:Roche Diagnostics (NZ) Ltd
15 Rakino Way
Mt Wellington
AUCKLAND 1644
Contact Information:0800 363 622
Manufacturer:Sysmex Corporation
Issue:It has been noticed that there is an increased frequency of false positive flags in the WDF channel. Upon investigation, the manufacturer determined there was a possibility of XN series instruments generating this problem due to certain lots of Lysercell WDF.
Recall action type:Recall
Recall action:Product to be destroyed
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:14/9/2017
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