VITROS Chemistry Products Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY

Reason: Ortho Clinical Diagnostics (OCD) confirmed the potential for lower than expected C-Reactive Protein (CRP) results only to be generated when using VITROS Chemistry Products Specialty Diluent (Lot F3168) or VITROS Chemistry Products FS Diluent Pack 3 (Lot 01-3266). The VITROS Instructions for Use states that if the if a C-reactive protein concentration exceeds the systems measuring (reportable or dynamic) range, dilute the sample with VITROS Specialty Diluent or a patient sample containing a low concentration of CRP. An initial threefold dilution is recommended. Internal testing determined that results using VITROS CRP Slides have the potential for approximately 51% bias using a 3x dilution factor.

Code information: Lot F3168 (exp. 30 Sep 2014)

Distribution pattern: Nationwide, Puerto Rico, and foreign distribution to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.