1) VITROS Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique Device Identifier No. 10758750002320, 20758750002327) and the 2)VITROS Immunodiagnostic Products Total Beta-hCG II Calibrators (Unique Device Identifier No. 10758750002337, 20758750002334); For quantitative measurement of human chorionic gonadotropin (hCG) and its beta subunit in human serum and plasma.

When testing was conducted using certain lots, VITROS Systems generated results within the measuring range for samples known to not contain measurable hCG. The system reported results up to approximately 7.40 mIU/mL (IU/L) for patient samples that should have been less than the measuring range of the assay (<2.39 mIU/mL (IU/L)).

On February 18, 2016, Ortho Clinical Diagnostics distributed Urgent Product Correction Notification letters and Confirmation of Receipt Forms to their customers (Ref. CL2016-043) via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail. Customers are advised to immediately discontinue using and discard all remaining inventory of the listed lots. Ortho Clinical Diagnostics will replace all remaining inventory or provide account credits as indicated on the confirmation of receipt form. Customers are advised to review previously reported results using the affected lots and to discuss these findings with your Laboratory Medical Director to determine the appropriate course of action. Post the notification by your VITROS System or with your user documentation. Complete and return the Confirmation of Receipt form to Joe Falvo via email at [email protected] or by fax to 1-888-557-3759 or to 1-585-453-4110. Clients with questions can contact Customer Technical Services at 1-800-421-3311 at any time.