BEUDAMED
    8 results · 37ms · Sources: EU EUDAMED, US FDA

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    K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM.

    FDA Recall
    Open, Classified ·Helena Laboratories, Corp.·Product code JPA·November 9, 2020

    SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems

    FDA Recall
    Open, Classified ·Helena Laboratories, Corp.·Product code JBD·February 27, 2018

    Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics

    FDA Recall
    Open, Classified ·Helena Laboratories, Corp.·Product code LXG·May 2, 2023

    V8 Immunodisplacement Kit REF 1803

    FDA Recall
    Open, Classified ·Helena Laboratories, Corp.·Product code CFF·April 6, 2022

    ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.

    FDA Recall
    Open, Classified ·Helena Laboratories, Corp.·Product code KHE·August 8, 2018

    Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen (equine tendon) For In-Vitro Diagnostic Use,

    FDA Recall
    Open, Classified ·Helena Laboratories, Corp.·Product code GHR·May 23, 2018

    Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies, Contains: 2X1 mL ADP Reagent containing adenosine diphosphate, 2X 1 mL Collagen Reagent containing collagen (equine tendon), 2 x 1 mL Epinephrine Reagent containing L-epinephrine, FOR IN-VITRO DIAGNOSTIC USE, Store at 2 to 8 C, 0011724/14(3)

    FDA Recall
    Open, Classified ·Helena Laboratories, Corp.·Product code GHR·May 23, 2018

    ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.

    FDA Recall
    Open, Classified ·Helena Laboratories, Corp.·Product code KHE·August 8, 2018