BEUDAMED
    FDA Recall Terminated

    ARCHITECT C-Peptide Reagent Kit; a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of C-Peptide in human serum, plasma and urine on the ARCHITECT i System; Produced by Biokit S.A., 08186 Barcelona, Spain for Abbott Diagnostics Division, Distributed by Abbott Laboratories, Abbott Park, IL 60064 USA and Abbott, 65205 Wiesbaden, Germany; list 3L53-25 The ARCHITECT C-Peptide assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of C-Peptide in human serum, plasma and urine on the ARCHITECT i System. The ARCHITECT C-Peptide assay is used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.

    Recall: Z-3031-2011 · Initiated July 11, 2011

    Recall

    Recall Number
    Z-3031-2011
    Event Number
    59335
    Firm
    Abbott Laboratories
    FEI Number
    1415939
    Product Code
    JKD
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 11, 2011
    Terminated
    February 10, 2012
    Address
    100 Abbott Park Rd, Abbott Park, IL, 60064-3502

    Description

    ARCHITECT C-Peptide Reagent Kit; a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of C-Peptide in human serum, plasma and urine on the ARCHITECT i System; Produced by Biokit S.A., 08186 Barcelona, Spain for Abbott Diagnostics Division, Distributed by Abbott Laboratories, Abbott Park, IL 60064 USA and Abbott, 65205 Wiesbaden, Germany; list 3L53-25 The ARCHITECT C-Peptide assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of C-Peptide in human serum, plasma and urine on the ARCHITECT i System. The ARCHITECT C-Peptide assay is used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.

    Reason

    C-Peptide lots 03610K000 and 01711A000 have the potential to generate falsely elevated results with certain patient samples and with non-Abbott Controls.

    Action

    Abbott Laboratories sent a "PRODUCT RECALL" letter dated July 11, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use of the lots and destroy any remaining inventory of the lots according to laboratory procedures. A Customer Reply form was provided to customers to complete and return via fax at 1-800-777-0051. Customers can contact Abbott Customer Service at 1-877-4ABBOTT for questions regarding this notice.

    Distribution

    Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Algeria, Argentina, Armenia, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, India, Indonesia, Ireland, Italy, Japan, Jordan, Latvia, Libya, Lithuania, Luxembourg, Malaysia, Mauritania, Mexico, Netherlands, Oman, Pakistan, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Korea, Spain, Switzerland, Taiwan, Trinidad & Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Venezuela.

    Quantity

    3,049 kits