BEUDAMED
    FDA Recall Terminated

    Vitros CRP (C-Reactive Protein) Slides. Catalog #192 6740 contains 250 slides; Catalog #809 7990 contains 90 slides. Firm on label: Ortho-Clinical Diagnostics, a Johnson & Johnson Company, Rochester, NY 14626.

    Recall: Z-0387-05 · Initiated November 22, 2004

    Recall

    Recall Number
    Z-0387-05
    Event Number
    30570
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    DCK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 22, 2004
    Posted
    January 8, 2005
    Terminated
    May 2, 2005
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101

    Description

    Vitros CRP (C-Reactive Protein) Slides. Catalog #192 6740 contains 250 slides; Catalog #809 7990 contains 90 slides. Firm on label: Ortho-Clinical Diagnostics, a Johnson & Johnson Company, Rochester, NY 14626.

    Reason

    Results may be negatively biased due to a non-linear response at the upper end of the Reportable (Dynamic) Range.

    Action

    Letters dated 11/22/2004 issued to customers. End users instructed to manually modify the Reportable and/or Analyzer Ranges; dilute all samples with an initial CRP result greater than 9.0 mg/dL. Distributors instructed to destroy product in-house and to notify end-users to manually modify the Reportable and/or Analyzer Ranges.

    Distribution

    Nationwide and worldwide distribution. 70% of product was shipped to foreign consignees.

    Quantity

    Cat. 1926740 - 20,903 boxes; Cat 8097990 - 34,877 boxes