24 results · 21ms · Sources: EU EUDAMED, US FDA

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ALINITY I TOTAL PSA REAGENT KIT

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

AUTOMATED PD SET W/CASSETTE4 PRONG

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 25, 2011

RESERVOIR 3ML

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·July 31, 2014

ARCHITECT TOTAL PSA

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MTF·February 25, 2026

ALINITY I TOTAL PSA REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MTF·May 20, 2025

ALINITY I TOTAL PSA REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MTF·April 21, 2025

ALINITY I TOTAL PSA REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MTF·December 16, 2025

ARCHITECT TOTAL PSA

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MTF·October 23, 2025

ALINITY I TOTAL PSA REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MTF·November 18, 2025

ALINITY I TOTAL PSA REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MTF·July 14, 2025

ALINITY I TOTAL PSA REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MTF·July 16, 2025

ALINITY I TOTAL PSA REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MTF·August 6, 2025

PULSE GEN MODEL 1000

FDA Adverse Event
Malfunction ·LIVANOVA USA, INC.·Product code LYJ·September 7, 2022

ALINITY I TOTAL PSA REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MTF·December 17, 2024

ALINITY I TOTAL PSA REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MTF·June 2, 2025

ALINITY I TOTAL PSA REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MTF·May 7, 2025

ALINITY I TOTAL PSA REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MTF·May 28, 2025

ALINITY I TOTAL PSA REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MTF·January 28, 2026

ALINITY I TOTAL PSA REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MTF·February 10, 2025

ALINITY I TOTAL PSA REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MTF·March 24, 2025