Medical device manufacturer, Ortho Clinical Diagnostics, has issued a medical device safety alert concerning its VITROS Chemistry Products Specialty Diluent Lot F3168 (Product Code 8559825) & VITROS Chemistry Products FS Diluent Pack 3 Lot 01-3266 (Product Code 6801754).

The manufacturer 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. When using the affected lots of diluent, results using VITROS CRP Slides may be negatively biased by approximately 51% using a 3X dilution factor.

The manufacturer advises affected users to take the following actions:-

• Immediately discontinue using and discard all remaining inventory of VITROS Specialty Diluent, Lot F3168 and/or VITROS FS Diluent Pack 3, Lot 01-3266.
• Review previously reported results using the affected lots. Discuss any concerns regarding previously reported results with their Laboratory Medical Director or with the requesting physician.

According to the manufacturer, the affected products were not distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 28 Mar 2014