BEUDAMED
    FDA Recall Terminated

    VITROS Immunodiagnostic Products Troponin I Reagent Pack, REF/Catalog No. 194 9882. A Troponin Immunoassay Method, IVD. Ortho-Clinical Diagnostics, Amersham UK

    Recall: Z-0820-2007 · Initiated April 27, 2007

    Recall

    Recall Number
    Z-0820-2007
    Event Number
    37873
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    MMI
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 27, 2007
    Posted
    May 26, 2007
    Terminated
    September 7, 2012
    Address
    100 Indigo Creek Drive, Rochester, NY, 14626-5101

    Description

    VITROS Immunodiagnostic Products Troponin I Reagent Pack, REF/Catalog No. 194 9882. A Troponin Immunoassay Method, IVD. Ortho-Clinical Diagnostics, Amersham UK

    Reason

    Quality control and patient results can be lower than expected when the true Troponin I value is less than or equal to 0.2 ng/mL which may result in the device failing to detect myocardial injury.

    Action

    On 4/27/07, Ortho-Clinical Diagnostics in Rochester, NY, notified the end users of the recall of the product by phone, fax, and FedEx overnight letter. Clinical labs in possession of these lots have been contacted by OCD, and were instructed to (a) discontinue use of this product and (b) notify healthcare providers who ordered the test in recent weeks. Replacement product has been provided to clinical labs with the affected product lots. Clinical laboratories with questions may contact the company at 1-800-421-3311. On 4/27/07, OCD foreign affiliates were informed of this action by e-mail and instructed to inform their customers who received these reagent packs of this issue. Ortho-Clinical Diagnostics in Raritan, NJ, issued a nationwide press release on 5/04/07.

    Distribution

    Worldwide-including USA, Canada, and Bermuda

    Quantity

    Lot 3151: 1,750 units, Lot 3170: 3,316 units