FDA-Device2014-03-19Class III
VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATALOG # 684 4055, IVD --- COMMON/USUAL NAME: VITROS Vitamin D Calibrators -- Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK --- For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic Systems, and the VITROS 5600 Integrated System for the quantitative measurement of total 25-OH Vitamin D in human serum.
Ortho-Clinical Diagnostics
Hazard
Ortho Clinical Diagnostics has determined that the VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators, Lots 0091 through 0235, used with VITROS Immunodiagnostic Products 25-OH Vitamin D Total Reagent Packs, may generate negatively biased results. As a result, users must immediately discontinue using all current lots of VITROS 25-OH Vitamin D Total Calibrators and Reagent Packs.
Sold states
Nationwide
Affected count
1554 units domestically
Manufactured in
100 Indigo Creek Dr, N/A, Rochester, NY, United States
Products
VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATALOG # 684 4055, IVD --- COMMON/USUAL NAME: VITROS Vitamin D Calibrators -- Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK --- For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic Systems, and the VITROS 5600 Integrated System for the quantitative measurement of total 25-OH Vitamin D in human serum.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1193-2014Don't want to check this manually?
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