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Type of Product	Medical Device
TGA Recall Reference	RC-2012-RN-00658-3
Product Name/Description	VITROS Chemistry Products DGXN Slides; An in vitro diagnostic medical device (IVD) Product Code: 8343386
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	2/07/2012
Responsible Entity	Ortho-Clinical Diagnostics
Reason/Issue	Ortho-Clinical Diagnostics, Inc. (OCD) recently received complaints of elevated results using heparin plasma samples for VITROS Chemistry Products DGXN Slides. As a result of their investigation into these complaints, heparin plasma is being removed as a recommended specimen type for VITROS DGXN Slides.
Recall Action	Recall for Product Correction
Recall Action Instructions	Laboratories are being advised to immediately discontinue using heparin plasma for VITROS DGXN Slides and to discuss previously reported results with the Laboratory Medical Director to determine appropriate course of action. Update your laboratory's Instructions for Use (IFU) Manual with the revised instructions that are provided with the recall notice.
Contact Information	1800 032 359 - Customer Technical Services