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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