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.
FDA Recall Z-1193-2014 · Posted 2014-03-12
Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Product CodeJIT
Date Initiated2014-01-15
Date Terminated2017-04-03
Product Quantity1554 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.
Firm 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.
Root Cause
Component design/selection
Distribution Pattern
Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.