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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00413-1
Product Name/Description VITROS Chemistry Products Specialty Diluent and VITROS Chemistry Products FS Diluent Pack 3

VITROS Chemistry Products Specialty Diluent
Product Code: 8559825
Lot Number: F3168
Expiry Date: 30 Sep 2014

VITROS Chemistry Products FS Diluent Pack 3
Product Code: 6801754
Lot Number: 01-3266
Expiry Date: 23 Sep 2014
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 7/04/2014
Responsible Entity Ortho-Clinical Diagnostics
Reason/Issue Ortho Clinical Diagnostics Inc confirmed reports of lower than expected C-Reactive Protein (CRP) results when using the affected lots of VITROS Specialty Diluent and VITROS FS Diluent Pack 3 to dilute samples tested on VITROS CRP Slides. Internal testing determined that results using VITROS CRP Slides may be negatively biased by approximately 51% using a 3X dilution factor.
Recall Action Recall for Product Correction
Recall Action Instructions Ortho Clinical Diagnostics is requesting their customers to discontinue use and discard any remaining stock from the affected lots of diluent. Replacements from unaffected lots are available. This action has been closed-out on 11/04/2016
Contact Information 1800 032 359 - Ortho Clinical Diagnostics Customer Technical Services