Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:21425
Brand Name:Sysmex XN-550 analyser
Model:
Affected:Sysmex XN-550
Software version:
Recalling Organisation:Roche Diagnostics (NZ) Ltd
15 Rakino Way
Mt Wellington
AUCKLAND 1644
Contact Information:0800 363 622
Manufacturer:Sysmex Corporation
Issue:The manufacturer has become aware that potentially inaccurate results could occur from improper mixing of a sample on the Sysmex XN-550 Automated Haematology Analyser when both of the following conditions occur:
1. The sample tube setup is for RBT micro collection tube or SARSTEDT sample tube
2. The XN-550 analyser is connected to a host computer and a host communication error occurs during a sampler run.
Recall action type:Correction
Recall action:Instructions for use to be updated
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:15/5/2017
Hide menus
Show menus
0 1 2 4 5 6 7 9 [ /