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ORTHO-CLINICAL DIAGNOSTICS recalls VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code 874 4468, Unique Identifier No. 10758750005147
Recalled August 10, 2016 · FDA recall Z-2302-2016 · ORTHO-CLINICAL DIAGNOSTICS
Hazard
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. · FDA Class II
Units
US: 12,015; Foreign: 55 Sales Units to Canada, 223 Sales Units shipped to Bermuda
Sold at
Worldwide Distribution - US (Nationwide including Puerto Rico) and foreign distribution to Canada and Bermuda
Description
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.
Product
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.
Manufacturer(s)
ORTHO-CLINICAL DIAGNOSTICS
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →