BEUDAMED
    FDA Recall Terminated

    VITROS Chemistry Products DT Calibrator Kit, REF/Catalog No. 195 7927, IVD --- Common/Usual Name: VITROS DT Calibrator Kit -- Ortho-Clinical Diagnostics, Inc. Rochester, NY -- Ortho-Clinical Diagnostics High Wycombe, UK VITROS Chemistry Products DT Calibrator Kit is an in vitro diagnostic specially formulated for use as calibrators for ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, Ca, CHOL, CK, Cl-, CO2, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.

    Recall: Z-0917-2012 · Initiated October 13, 2011

    Recall

    Recall Number
    Z-0917-2012
    Event Number
    60799
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    JIX
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    October 13, 2011
    Posted
    January 27, 2012
    Terminated
    February 12, 2016
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101

    Description

    VITROS Chemistry Products DT Calibrator Kit, REF/Catalog No. 195 7927, IVD --- Common/Usual Name: VITROS DT Calibrator Kit -- Ortho-Clinical Diagnostics, Inc. Rochester, NY -- Ortho-Clinical Diagnostics High Wycombe, UK VITROS Chemistry Products DT Calibrator Kit is an in vitro diagnostic specially formulated for use as calibrators for ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, Ca, CHOL, CK, Cl-, CO2, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.

    Reason

    Ortho Clinical Diagnostics (OCD) was notified by customers of negatively biased quality control results obtained while using VITROS Chemistry Products NBIL DT Slides, GEN 72. OCD performed an internal investigation and confirmed that negatively biased NBIL results could occur for quality control, proficiency and patient samples. As a result, VITROS Chemistry Products DT Calibrator Kit Lots 37 &

    Action

    Ortho Clinical Diagnostics (Johnson & Johnson Company) sent an Important Product Correction Notification letter dated October 13, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to recalibrate and instructing them to recalibrate VITROS Chemistry Products NBIL DT Slides, GEN 72 with updated DT calibrator values for the NBIL assay provided on CDM 0164. J&J Foreign affiliate consignees were notified by e-mail on October 13, 2011, informing them of the issue and of the availability of the updated CDM (0164). Consignees were instructed to complete and return the attached Confirmation of Receipt form upon receipt of the notification even if they do not use VITROS NBIL Slides in their facility. If the affected product was distributed outside the consignees facility they were instructed to forward the notification letter to affected customers. For any questions regarding this recall call 1-800-421-3311.

    Distribution

    Worldwide Distribution - USA (nationwide) Puerto Rico and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, and Venezuela

    Quantity

    12,750 units (Lot 37: domestic - 1403, foreign - 3488; Lot 38: domestic - 50, foreign - 30)