Recall Z-1193-2014— Ortho-Clinical Diagnostics

Name: FDA recall Z-1193-2014
Creator: U.S. Food and Drug Administration
Published: 2014-01-15

Class III · Terminated

Class III FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2014-01-15, terminated 2017-04-03. It names one FDA 510(k) clearance: K121608. Product: 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.. Reason: 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..

Recalling firm: Ortho-Clinical Diagnostics
Classification: Class III
Status: Terminated
Initiated: 2014-01-15
Terminated: 2017-04-03
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K121608 — VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORSOrtho-Clinical Diagnostics, Inc.·cleared 2013-02-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.