BEUDAMED
    FDA Enforcement Class II 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 · Reported September 5, 2018

    Enforcement

    Recall Number
    Z-2923-2018
    Event ID
    80554
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Tecan US, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 5, 2018
    Initiation Date
    January 12, 2018
    Classification Date
    August 24, 2018
    Termination Date
    June 2, 2020
    Address
    9401 Globe Center Dr Ste 140, N/A, Morrisville, NC, 27560-6211, United States

    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.

    Code Info

    In USA RE62119 Lot # LCL129 exp. date: 2017-11-30, RE62119 Lot # LCL133 exp. date: 2019-03-31, and RE62111 Lot # LCL130 exp. date: 2018-03-31. OUS Lot 131, Lot 132

    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)