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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