BEUDAMED
    FDA Recall Terminated

    Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva Luminescence immunoassay is intended for the in-vitro diagnostic quantitative determination of Cortisol in human saliva and for use as an aid in the diagnosis and treatment of adrenal disorders. The device is not intended for point-of-care settings.

    Recall: Z-2923-2018 · Initiated January 12, 2018

    Recall

    Recall Number
    Z-2923-2018
    Event Number
    80554
    Firm
    Tecan US, Inc.
    FEI Number
    1037985
    Product Code
    NHG
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 12, 2018
    Terminated
    June 2, 2020
    Address
    9401 Globe Center Dr, Ste 140, Morrisville, NC, 27560-6211

    Description

    Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva Luminescence immunoassay is intended for the in-vitro diagnostic quantitative determination of Cortisol in human saliva and for use as an aid in the diagnosis and treatment of adrenal disorders. The device is not intended for point-of-care settings.

    Reason

    Product is not meeting specification for traceability to NIST cortisol standard, generating 1.3-1.8 times higher cortisol values with laboratory samples in comparison to NIST cortisol standard.

    Action

    The firm, IBL International, sent an "Urgent Field Corrective Action" letter dated 1/12/2018 via registered mail to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to examine your stock and affected lots; contact all customers and provide the letter; if you have any of the affected product, stop using and quarantine/scrap all remaining product from lots LCL129 up to LCL 133. Review results generated with affected lots and follow your laboratory standard operational procedures to review any potential aberrant results that may have occurred; complete and return the Customer Response Form by fax to:1-919-287-2961; email to:[email protected] or mail to: Attention: Tecan QA, 9401 Globe Center Dr., Suite 140, Morrisville, North Carolina 27560,United States to confirm receipt and actions. The firm is expect to have a new lot of Cortisol Saliva LUM available to ship by the end of February 2018. if you have any questions, please contact your local Tecan Helpdesk or IBL or Sr. Director Global Regulatory Affairs at 919-943-7118 or email: [email protected].

    Distribution

    Worldwide distribution; US distribution to states of: GA, IA, LA, MA, MN, OR, PA, SC, and UT; and countries of: Germany, Finland, Switzerland, France, Austria, Denmark, Poland, Norway, Belgium, Netherlands, Italy, Canada, South Africa, Russia, and Japan.

    Quantity

    870 (USA) 180 (OUS)