BEUDAMED
    FDA Recall Terminated

    VITROS Chemistry Products Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY

    Recall: Z-1519-2014 · Initiated March 26, 2014

    Recall

    Recall Number
    Z-1519-2014
    Event Number
    67883
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 26, 2014
    Posted
    April 28, 2014
    Terminated
    March 27, 2017
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101

    Description

    VITROS Chemistry Products Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY

    Reason

    Ortho Clinical Diagnostics (OCD) confirmed the potential for lower than expected C-Reactive Protein (CRP) results only to be generated when using VITROS Chemistry Products Specialty Diluent (Lot F3168) or VITROS Chemistry Products FS Diluent Pack 3 (Lot 01-3266). The VITROS Instructions for Use states that if the if a C-reactive protein concentration exceeds the systems measuring (reportable or dynamic) range, dilute the sample with VITROS Specialty Diluent or a patient sample containing a low concentration of CRP. An initial threefold dilution is recommended. Internal testing determined that results using VITROS CRP Slides have the potential for approximately 51% bias using a 3x dilution factor.

    Action

    On 3/26/2014, Urgent Product Correction Notification Letters were sent via FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees (OCD Direct, Drop-Ship and US Federal Government) to inform them of the issue and advise them to discontinue use of the affected lot(s), discard the affected lots and to inform their Laboratory Medical Director if they suspect that a previously reported result may have been affected. Replacement product will be sent for the product discarded. J&J Foreign affiliate consignees were notified by e-mail informing them of the issue on 3/26/2014.

    Distribution

    Nationwide, Puerto Rico, and foreign distribution to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.

    Quantity

    1656 distributed (1200 went to warehouse in France)