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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 VITROSĀ® Na+ Slides calibrated with Lots 212 and 292. It is acceptable to use Lot 212 or 292 to calibrate VITROSĀ® 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