BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1795-2026 · Initiated March 12, 2026

    Recall

    Recall Number
    Z-1795-2026
    Event Number
    98561
    Firm
    Brahms GmbH Neuendorfstr. 25 Hennigsdorf Germany
    FEI Number
    3003561301
    Product Code
    QWH
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 12, 2026
    Posted
    April 8, 2026

    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.

    Action

    On 2/27/2026, correction notices were sent to customers informing them: 1. Continue to perform Quality Control testing in accordance with the current Instructions for Use prior to reporting patient results. 2. If Quality Control results fall outside plus-minus 20% of target values follow the troubleshooting procedures described in the User Manual. 3. Forward this letter to those who need to be aware within your organization or to any organization to whom the potentially affected devices have been transferred. Keep this notification on file. For further questions, please contact the firm's customer service on 1-800-232-3342 or e-mail to: [email protected]

    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