Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-01098-1
Product Name/Description	VITROS 3600 and 5600 Systems using Software Version 3.2 and Below. An in vitro diagnostic medical device (IVD) VITROS 3600 System Product Code: 6802783 VITROS 3600 System Software Version 3.2 & Below Product Code: 6802866 VITROS 5600 System Product Code: 6802413 VITROS 5600 System Software Version 3.2 & Below Product Code: 6802864 ARTG Number: 180199
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	13/11/2015
Responsible Entity	Ortho-Clinical Diagnostics
Reason/Issue	Due to a software anomaly, the temperature in the Well Wash module may be out or range without notification to the operator. Temperature monitoring is performed by the VITROS System for each subsystem (i.e. MicroSlide, MicroTip and MicroWell). Ortho-Clinical's investigation confirmed that under very specific conditions, the temperature for the Well Wash module may be out of range without alerting the operator.. If the anomaly occurs, it is possible for the VITROS System to process samples outside of the proper temperature range, potentially leading to biased patient result. The results will not have the proper ‘WT’ (Wash Temperature) result code.
Recall Action	Recall for Product Correction
Recall Action Instructions	Ortho-Clinical is providing users with a guide to determine if the unit is affected by the temperature issue. If a temperature is out of range and the status bar indicates that the system is “Ready” or the temperature icon is NOT present, the user is advised to contact the sponsor’s Technical Solutions Centre. Ortho-Clinical is advising users to discuss any concerns regarding previously reported results with the Laboratory Director. This action has been closed-out on 29/08/2016.
Contact Information	1800 032 359 - Technical Solutions Centre