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U.S. Department of Health and Human Services

Class 3 Device Recall VITROS Immunodiagnostic Products 25OH Vitamin D Total Calibrators

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  Class 3 Device Recall VITROS Immunodiagnostic Products 25OH Vitamin D Total Calibrators see related information
Date Initiated by Firm January 15, 2014
Date Posted March 12, 2014
Recall Status1 Terminated 3 on April 03, 2017
Recall Number Z-1193-2014
Recall Event ID 67439
510(K)Number K121608  
Product Classification Clinical Chemistry secondary Calibrator - Product Code JIT
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.
Code Information 0020, 0030, 0040, 0050, 0060, 0070, 0081, 0090, 0100, 0110
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information Contact Ms. Jennifer Paine
908-218-8776
Manufacturer 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.
FDA Determined
Cause 2		 Component design/selection
Action On 1/22/2014, Customer Letters were sent via FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees to inform them of the issue and advise them to discontinue use of the affected lot(s) and to inform their Laboratory Medical Director if they suspect that a previously reported result may have been affected. On 1/22/2014, Distributor Letters were sent via US Postal Service Priority Mail and/or FedEx overnight courier to US distributor consignees and instructed them to notify their consignees of the issue and actions.
Quantity in Commerce 1554 units domestically
Distribution Nationwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JIT and Original Applicant = Ortho-Clinical Diagnostics, Inc.
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