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    78 results · 24ms · Sources: EU EUDAMED, US FDA

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    Alinity i Total ß-hCG Reagent Kit, Alinity i System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ALINITY I TOTAL B-HCG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 3, 2026

    ALINITY I TOTAL B-HCG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·April 1, 2026

    ALINITY I TOTAL B-HCG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·April 28, 2026

    ALINITY I TOTAL B-HCG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·April 6, 2026

    ALINITY I TOTAL B-HCG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·August 18, 2025

    ALINITY I TOTAL B-HCG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 20, 2026

    ALINITY I TOTAL B-HCG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·March 30, 2026

    ALINITY I TOTAL B-HCG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 22, 2026

    ALINITY I TOTAL B-HCG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 22, 2026

    ALINITY I TOTAL B-HCG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 6, 2026

    ALINITY I TOTAL B-HCG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 29, 2026

    ALINITY I TOTAL B-HCG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·December 18, 2024

    ALINITY I TOTAL B-HCG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·February 6, 2026

    ALINITY I TOTAL B-HCG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·March 16, 2026

    ALINITY I TOTAL B-HCG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·November 24, 2025

    ALINITY I TOTAL B-HCG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·December 24, 2025

    ALINITY I TOTAL B-HCG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·November 17, 2025

    ALINITY I PROCESSING MODULE

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code JJE·October 8, 2025

    ALINITY I TOTAL B-HCG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·November 20, 2025