FDA-Device2014-05-28Class II
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.
Ortho-Clinical Diagnostics
Hazard
Total T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results.
Sold states
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.
Affected count
583 units Total (357 units domestically & 226 units internationally)
Manufactured in
100 Indigo Creek Dr, N/A, Rochester, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1648-2014Don't want to check this manually?
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