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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-01050-1
Product Name/Description	QConnect HBVNAT Positive Part Number: 969053 Lot Numbers: 431510 and 520503 ARTG Number: 249133
Recall Action Level	Hospital
Recall Action Classification	Class III
Recall Action Commencement Date	5/11/2015
Responsible Entity	Thermo Fisher Scientific Australia Pty Ltd
Reason/Issue	Certain lot numbers of the QConnect HBVNAT Positive control may give no results due to IC (Internal Control) failure when run on the Abbott m2000. The affected lot numbers should not be run on the Abbott m2000. To ensure all affected lots have been destroyed the respective Product Specialist for each area will visit each site to confirm there is no stock still in possession.
Recall Action	Recall
Recall Action Instructions	Users are asked to quarantine all affected units from use prior to destruction. To ensure all affected lots have been destroyed the respective Product Specialist for each area will visit each site to confirm there is no stock still in possession. This action has been closed-out on 22/08/2016.
Contact Information	(02) 8817 4279 - Thermo Fisher Scientific