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Type of Product	Medical Device
TGA Recall Reference	RC-2012-RN-01143-1
Product Name/Description	VITROS Chemistry Products HPT Reagent. An in vitro diagnostic medical device (IVD) Product code: 6802214 Lot number: 1533-19-2133 (Assay identifier 1533, GEN 19, Lot 2133); Expiration date: 20 Nov 2012 Lot Number: 1533-20-2314 (Assay identifier 1533, GEN 20, Lot 2314); Expiration date: 11 Feb 2012
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	13/11/2012
Responsible Entity	Ortho-Clinical Diagnostics
Reason/Issue	Customers have reported the inability to calibrate VITROS HPT Reagent due to an increase in "U91-274" condition codes. In cases of successful calibration, some customers have also reported an increase in "U91-274" condition codes that prevented results when processing patient samples and quality control fluids. A potential for biased results exists if the user is able to obtain a valid calibration and quality control (QC) may not detect the issue.
Recall Action	Recall
Recall Action Instructions	Discontinue and discard remaining inventory of VITROS HPT Reagent. Ortho-Clinical Diagnostics recommends discussing previously reported results with the Laboratory Director to determine the appropriate course of action.
Contact Information	1800 032 359 - Ortho-Clinical Diagnostics Technical Support Centre