VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code 874 4468, Unique Identifier No. 10758750005147, IVD --- Ortho-Clinical Diagnostics, For in vitro diagnostic use only. For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.

Ortho-Clinical Diagnostics confirmed that sample results generated from VITROS Immunodiagnostic Products Total T4 Reagent Packs may show a negative bias prior to the open pack storage limit of <= 8 weeks that is located in the Instructions for Use (IFU) for VITROS Immunodiagnostic Products Total T4 Reagent Pack.

Ortho Clinical Diagnostics sent an Important Product Correction Notification letter (Ref. CL2016-112) dated June 2, 2016, to all affected customers via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers who received the affected product to inform them that sample results generated using VITROS Total T4 Reagent Packs that are opened for more than 4 weeks may produce a negative bias and advised them to only use the Total T4 Reagent Pack up to 4 weeks after the pack has been opened. Foreign affiliates were informed of the issue by e-mail on 6June 2, 2016, and instructed to notify their consignees of the issue and required actions. Customers with questions were instructed to contact Global Technical Solutions Center at 1-800-421-3311.