BEUDAMED
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    I-STAT CHEM8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JPI·March 4, 2025

    UNKNOWN LAG SCREW

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HSB·July 2, 2024

    UNKNOWN AFFIXUS NATURAL NAIL HUMERAL NAIL SYSTEM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HSB·June 26, 2024

    UNKNOWN AFFIXUS NATURAL NAIL HUMERAL NAIL SYSTEM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HSB·June 26, 2024

    I-STAT CHEM8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·February 15, 2022

    I-STAT CARTRIDGE

    FDA Adverse Event
    Injury ·ABBOTT POINT OF CARE·Product code CHL·August 8, 2014

    Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·February 11, 2015

    UNKNOWN SHOULDER CONSTRUCT DELTA XTEND

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWS·June 19, 2025

    ATELLICA CH

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JGS·May 30, 2025

    COBAS B 221 <6> SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code CHL·March 30, 2026

    Access Immunoassay Systems Part Number: 81600 Access 2 Immunoassay Systems Part Number: 81600N Access Immunoassay Systems LXi 725 Part Number: 386200 Subsequent Product Codes: JGS The Access/DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code JJE·April 15, 2011

    ABL 80 CO-OX SYSTEM, software versions 1.30 and 1.31 Additional Product Codes: CEM, CGA, CGZ, GHS, GKR, GLY, JFP, JGS, JIX, JJY, JPI The ABL 80 CO-OX SYSTEM is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL 80 CO-OX SYSTEM is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.

    FDA Recall
    Terminated ·Sendx Medical Inc·Product code CHL·February 20, 2009

    I-STAT CG8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·November 14, 2016

    I-STAT CHEM8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·July 5, 2015

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JGS·January 13, 2012

    OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER MISHIMA K.K.·Product code JGS·February 6, 2012

    UNICEL DXC 600 SYNCHRON SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JGS·March 29, 2012

    DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code JGS·February 21, 2012

    OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER MISHIMA K.K.·Product code JGS·January 3, 2012

    COBAS INTEGRA 400 PLUS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JGS·January 26, 2012