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U.S. Department of Health and Human Services

Enforcement Report - Week of March 19, 2014

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Product Detail

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.
Recall Number Z-1193-2014
Classification Class III
Code Info 0020, 0030, 0040, 0050, 0060, 0070, 0081, 0090, 0100, 0110
Product Distributed Qty 1554 units domestically
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.

Event Detail

Event Id 67439
Product Type Devices
Status Ongoing
Recalling Firm Ortho-Clinical Diagnostics
City Rochester
State NY
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-01-15
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide