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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-00485-1
Product Name/Description Sysmex XN-550 Automated Haematology Analyser. An in vitro diagnostic medical device (IVD)

ARTG Number: 173886
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 4/05/2017
Responsible Entity Roche Diagnostics Australia Pty Limited
Reason/Issue Sysmex have found that that potentially inaccurate results could occur from improper mixing of a sample on the Sysmex XN-550 Automated Haematology Analyser with the following conditions:
- The sample tube setup is for RBT micro collection tube or Sarstedt sample tube, AND
- The XN-550 analyser is connected to a host computer and a host communication error occurs during a sampler run.

If there is a sample tube located in the sample tube holder at this time, it will not be processed until the operator accepts the error message. Sedimentation of the blood sample could occur during this time between error display and acceptance of the error, leading to potentially inaccurate results because the sample is processed without additional mixing. Sysmex has found this issue is due to a software bug.
Recall Action Recall for Product Correction
Recall Action Instructions Roche is advising users that this issue will be resolved in a software update that is expected to be released in May 2017 and will be installed by Roche personnel. Roche will contact users to arrange for the installation. In the interim, laboratories that use RBT micro collection tubes and/or Sarstedt sample tubes are advised to follow the directions provided in the customer letter when an error message related to a host communication and/or TCP/IP connection occurs.

This action has been closed out on 14/11/2018
Contact Information 02 9860 2357 - Roche Diagnostics