BEUDAMED
    FDA Enforcement Class II Ongoing

    B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental Growth Factor

    Recall: Z-1795-2026 · Reported April 15, 2026

    Enforcement

    Recall Number
    Z-1795-2026
    Event ID
    98561
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Brahms GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    April 15, 2026
    Initiation Date
    March 12, 2026
    Classification Date
    April 8, 2026
    Address
    Neuendorfstr. 25, Hennigsdorf, N/A, Germany

    Description

    B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental Growth Factor

    Reason

    Customers have observed quality control values out of range at the lowest quality control level (QC Level 1) for the PIGF assay which require troubleshooting steps to resolve. If Quality Controls are not performed according to the Instructions for Use, the underestimation of QC1 may go undetected and could contribute to falsely elevated sFlt-1/PlGF ratio results. A falsely elevated sFlt-1/PlGF ratio may result in a higher-risk classification for progression to preeclampsia with severe features potentially leading to intensified clinical monitoring.

    Code Info

    UDI: 04260157632196. Lot(Expiration): 59172(2026-11-23), 859075N(2026-11-23)

    Distribution

    Worldwide distribution. US states: NC, TX, MN, UT, NY, FL, OH, IL, CT, CA, GA. Other countries: DE, AT, AL, AU, BG, BR, CA, CH, CZ, DK, ET, ES, FR, GB, GR, HK, HU, ID, IL, IT, KW, KZ, LT, MK, ML, MX, NL, NO, PA, PL, PT, RO, SE, SI, TH, TU, TW, UA, ZA

    Quantity

    5,254