BEUDAMED
    FDA Recall Terminated

    IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T, L2KTS6 - 600T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).

    Recall: Z-1885-2013 · Initiated May 10, 2013

    Recall

    Recall Number
    Z-1885-2013
    Event Number
    65162
    Firm
    Siemens Healthcare Diagnostics, Inc
    FEI Number
    1219913
    Product Code
    JLW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 10, 2013
    Posted
    August 6, 2013
    Terminated
    May 10, 2016
    Address
    333 Coney St, East Walpole, MA, 02032-1516

    Description

    IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T, L2KTS6 - 600T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).

    Reason

    A rare variant of TSH, identified in a small cluster of patients, is not detected.

    Action

    On May 10, 2013, an Important Safety Information notice was sent to all affected Siemens Healthcare Diagnostic customers in the United States. On May 10, 2013, an Urgent Field Safety Notice was sent to all customers outside of the United States. These notices inform the customer that there is a rare variant of TSH, identified in a small cluster of patients that is not detected by some Siemens assays. This notice informs customers that they should continue to use the affected TSH assays as the observed rate of occurrence during a 30-month time period was 0.6 X 10 -7 and there are strong mitigating factors. These mitigating factors include co-interpretation of TSH results in conjunction with thyroxine and TS, patient history and clinical signs and symptoms. Although Siemens believes a look back is not required as the expected frequency of the variant is extremely rare, these notices state that this decision should be made by the medical director.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Canada, AE, AR, AT, AU, BA, BD, BE, BG, BO, BR, BY, CH, CL, CM, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KA, KR, KW, KZ, LB, LK, LT, LV, LY, MA, MK, MT, MX, MY, NI, NL, NO, NP, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RU, SA, SE, SG, SK, SV, SY, TH, TM, TN, TR, TW, UA, UY, UZ, VE, VN, XS, and ZA.

    Quantity

    51792