BEUDAMED
    FDA Recall Terminated

    VITROS Chemistry Products GLU DT Slides GEN 56, REF (Catalog #) 153 2316, 25 slides per box. VITROS Chemistry Products GLU DT Slides quantitatively measure glucose (GLU) concentration in serum and plasma. Ortho-Clinical Diagnostics, a Johnson & Johnson company. Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626. .

    Recall: Z-0151-2007 · Initiated September 27, 2006

    Recall

    Recall Number
    Z-0151-2007
    Event Number
    36509
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    CGA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 27, 2006
    Posted
    November 4, 2006
    Terminated
    August 3, 2012
    Address
    100 Indigo Creek Drive, Rochester, NY, 14626-5101

    Description

    VITROS Chemistry Products GLU DT Slides GEN 56, REF (Catalog #) 153 2316, 25 slides per box. VITROS Chemistry Products GLU DT Slides quantitatively measure glucose (GLU) concentration in serum and plasma. Ortho-Clinical Diagnostics, a Johnson & Johnson company. Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626. .

    Reason

    Positively biased results when using the VITROS Chemistry Products GLU DT Slides GEN 56.

    Action

    On 9/26/06, the recalling firm notified its foreign affiliate consignees of this 'field correction', and instructed them to inform their customers who received these slides of this issue, provided them with an updated Calibration Data Module and instructed to re-calibrate these slides for continued use. On 9/27/06, all US end-use consignees were informed of this issue via Federal Express overnight letter (dated 9/27/06), and instructing them to re-calibrate these slides for continued use after they have installed the Calibration Data Module. The new CDMs were sent to all customers with VITROS DT 60/DT60 II Chemistry systems starting 9/27/06 concurrent with, but separate, from the correction letters. This includes consignees who purchased their GLU DT slides from distributors. On 9/28/06, all distributors were notified of this 'field correction', providing instructions and 'Questions & Answers' for them, and instructing them to inform their customers who received these slides of this issue. Calibration Data Modules were sent to all customers with VITROS DT 60/DT60 II Chemistry Systems.

    Distribution

    Worldwide Distribution

    Quantity

    93,252 boxes (25 slides per box) in total