BEUDAMED
    FDA Enforcement Class II Ongoing

    Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6;

    Recall: Z-0366-2026 · Reported November 5, 2025

    Enforcement

    Recall Number
    Z-0366-2026
    Event ID
    97672
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 5, 2025
    Initiation Date
    September 22, 2025
    Classification Date
    October 27, 2025
    Address
    333 Coney St, N/A, East Walpole, MA, 02032-1516, United States

    Description

    Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6;

    Reason

    The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal to 5.3 pmol/L), when using specific lots identified by the firm on the IMMULITE 2000/IMMULITE 2000 XPi systems. The bias is observed in both serum and plasma samples.

    Code Info

    1. Siemens Material Number (SMN): 10381441; Catalog Number: L2KPP2; UDI-DI: 00630414961910; Lot Number: 385, ***Expanded 2/18/2026*** 387, 388, 389; 2. Siemens Material Number (SMN): 10381442; Catalog Number: L2KPP6; UDI-DI: 00630414961927; Lot Number: 385, ***Expanded 2/18/2026*** 387, 388, 389;

    Distribution

    Worldwide - US Nationwide distribution in the states of AL, CA, DC, FL, ID, IN, LA, MD, NC, NJ, NY, PA, SC and the countries of Argentina, Australia, Bolivia, Bosnia Herzeg, Brazil, Bulgaria, Canada, Chile, Colombia, Cyprus, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Honduras, Hungary, India, Iran, Israel, Italy, Kosovo, Kuwait, Latvia, Lebanon, Macedonia, Mexico, Nepal, Netherlands, P.R. China, Pakistan, Palestinian Ter, Paraguay, Peru, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovakia, Slovenia, South Africa, Spain, Taiwan, Tunisia, Turkey, Turkmenistan, U.A.E., Ukraine, Uruguay, Uzbekistan.

    Quantity

    3318 units (169 US, 3149 OUS)