BEUDAMED
    FDA Enforcement Class II Ongoing

    IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)

    Recall: Z-0464-2025 · Reported November 20, 2024

    Enforcement

    Recall Number
    Z-0464-2025
    Event ID
    95513
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 20, 2024
    Initiation Date
    September 30, 2024
    Classification Date
    November 14, 2024
    Address
    333 Coney St, N/A, East Walpole, MA, 02032-1516, United States

    Description

    IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)

    Reason

    The IMMULITE 2000 PSA assay for use on the IMMULITE 2000 and IMMULITE 2000 XPi analyzers did not meet the High-dose Hook Effect claim as stated in the Instructions for Use (IFU).

    Code Info

    SMN 10706281: UDI - 00630414982212, Lot Number D164; SMN 10706282: UDI - 00630414982229, Lot Number D166; SMN 10380896 (OUS): UDI - 00630414961958; SMN 10380996 (OUS): UDI - 00630414961965; OUS Lot Numbers: 438, 439, 440

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    7,332 units