BEUDAMED
    FDA Enforcement Class II Ongoing

    IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers for the quantitative measurement of total testosterone in serum and heparinized plasma.

    Recall: Z-0355-2023 · Reported December 14, 2022

    Enforcement

    Recall Number
    Z-0355-2023
    Event ID
    91108
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 14, 2022
    Initiation Date
    October 25, 2022
    Classification Date
    December 2, 2022
    Address
    333 Coney St, N/A, East Walpole, MA, 02032-1516, United States

    Description

    IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers for the quantitative measurement of total testosterone in serum and heparinized plasma.

    Reason

    Confirmed an average positive bias of 40% for testosterone concentrations of approximately 660 ng/dL (22.9 nmol/L) and above with the IMMULITE/IMMULITE 1000 Total Testosterone Assay when compared to the IMMULITE 2000/IMMULITE 2000 XPi Total Testosterone Assay. Two (2) lots of Total Testosterone assays for the IMMULITE/IMMULITE 1000, kit lots #515 and #516 were actively distributed to customers when the issue was discovered by Siemens, and they are subject to the correction or removal in this recall (867 total quantity of reagents distributed for each lot). The violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. In both males and female, testosterone results are not used in isolation but are interpreted in conjunction with clinical history and symptomology as well as with other laboratory testing (e.g. gonadotropins and other sex steroids). A delay in the diagnosis may be experienced and medical intervention, such as repeat testing may be required.

    Code Info

    UDI: (01)00630414964782(10)0515(17)20221130; (01)00630414964782(10)0516(17)20221231 Lot Numbers: 515, Exp Date: 2022-11-30 516, Exp Date: 2022-12-31

    Distribution

    Worldwide Distribution: US (nationwide) to states of: AL, CA, FL, GA, IN, KY, NC, NE, OR, SD, TX, UT; and OUS (Foreign) to countries of: Canada, Mexico, Austria, Argentina, Austria, Bangladesh, Colombia, Brazil, Bulgaria, Costa¿Rica, Cyprus, Estonia, Germany, Greece, India, U.A.E., Italy, Kazakhstan, Latvia, P.R.¿China, Romania, Russian¿Fed., South Africa, Spain, United Kingdom, Uruguay and Singapore.¿¿¿¿

    Quantity

    867 units