BEUDAMED
    38 results · 12ms · Sources: EU EUDAMED, US FDA

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    HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code GJS·October 13, 2021

    directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2

    FDA Recall
    Open, Classified ·Accriva Diagnostics, Inc.·Product code GGN·April 30, 2026

    Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System

    FDA Recall
    Open, Classified ·Accriva Diagnostics, Inc.·Product code JBP·November 5, 2025

    GEM Premier 5000; Part No. 00055445008.

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code CHL·January 20, 2026

    GEM Premier 5000; Part No. 00055415008.

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code CHL·January 20, 2026

    GEM Premier 5000; Model No. 00055430010.

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code CHL·January 20, 2026

    GEM Premier 5000; Part No. 00055430011.

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code CHL·January 20, 2026

    GEM Premier 5000; Part No. 00055430004.

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code CHL·January 20, 2026

    GEM Premier 5000; Part No: 00055415011.

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code CHL·January 20, 2026

    GEM Premier 5000; Part No. 00055430008.

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code CHL·January 20, 2026

    GEM Premier 5000; Part No. 00055415005.

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code CHL·January 20, 2026

    GEM Premier 5000; Part No. 00055445004.

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code CHL·January 20, 2026

    GEM Premier 5000; Part No. 00055415010.

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code CHL·January 20, 2026

    GEM Premier 5000 PAK; Part No. 00055415004.

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code CHL·January 20, 2026

    GEM Premier 5000; Part No. 00055445010 & 00055445011.

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code CHL·January 20, 2026

    GEM Premier 5000 PAK; Part No. 00055360010.

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code CHL·January 20, 2026

    GEM Premier 5000 PAK; Part No. 00055407510.

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code CHL·January 20, 2026

    GEM Premier 5000 PAK, Part No. 00055360004.

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code CHL·January 20, 2026

    GEM Premier 5000 PAK; Part No. 00055360011.

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code CHL·January 20, 2026

    GEM Premier 5000 PAK; Part No. 00055360008.

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code CHL·January 20, 2026