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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-01099-1
Product Name/Description	VITROS Chemistry Products Na+ Slides and Calibrator Kit 2 (used on VITROS 250/350/5, 1 FS, 4600 Chemistry Systems, VITROS 5600 Integrated System). An in vitro diagnostic medical device (IVD) VITROS Chemistry Products Na+ Slides Product Code: 8379034 Lot Numbers: GENs 7 to 13 Expiry Dates: 01/11/2013 to 01/01/2015 VITROS Chemistry Products Calibrator Kit 2 Product Code: 1662659 Lot Numbers: 212, 292 Expiry Dates: 31/08/2014, 28/02/2014
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	25/10/2013
Responsible Entity	Ortho-Clinical Diagnostics
Reason/Issue	Ortho Clinical Diagnostics (OCD) has conformed that positively biased serum or plasma sample results may occur by up to +1.5mmol/L.
Recall Action	Recall
Recall Action Instructions	OCD will replace your remaining inventory for VITROS® Na+ Slides calibrated with Lots 212 and 292. It is acceptable to use Lot 212 or 292 to calibrate VITROS® CHOL, Cl-, ECO2, and TRIG Slides until your replacement product arrives. This action has been closed-out on 01/02/2016.
Contact Information	1800 032 359 - Customer Technical Service