Vitros Immunodiagnostic Products 25-Oh Vitamin D Total Reagent Pack, Vitamin D Total Calibrators

• • Terminated Z-1193-2014 FDA Class III ·initiated 15 Jan 2014 ·on shared 510(k) K121608

  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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K121608 ↗

FDA Product Code

MRG

Device Class

Class II

Regulation

21 CFR Part 862.1825

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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