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Ortho-Clinical Diagnostics recalls VITROS TT4 Calibrator For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or hep
Recalled May 28, 2014 · FDA recall Z-1648-2014 · Ortho-Clinical Diagnostics
Hazard
Total T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results. · FDA Class II
Units
583 units Total (357 units domestically & 226 units internationally)
Sold at
Worldwide Distribution - USA (nationwide) and the countries of Australia, Brazil, Canada, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, Germany, Italy and Spain.
Description
Total T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results.
Product
VITROS TT4 Calibrator 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
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →