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    Cobas b 123 POC system cobas b 123 POC system is fully automated POC system for whole blood in vitro measurement of pH, blood gases (BG), electrolytes Na+ K+, iCa2+ (ISE), hematocrit (Hct), metabolites (Gluc, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHB, COHB, MetHb), and oxygen saturation (SO2). In addition, the cobas b 123 POC system calculates derived parameters. It is dedicated for use in a Point-of-Care environment and laboratory.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code CHL·November 14, 2012

    Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes Nat, K+, iCaWt (ISE), hematocrit (THct), metabolites (Glu, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHb, COT~b, MetHb), and oxygen saturation (SO2). In addition, the cobas b 123 POC system calculates derived parameters. It is dedicated for use in a Point-of-Care environment and laboratory. The integrated AutoQC module and the oximeter module are available as an option

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code CHL·September 3, 2015

    Thyrotest TSH POC Rapid membrane test. In vitro diagnostic.

    FDA Recall
    Terminated ·ThyroTec Inc·Product code JLW·January 24, 2007

    cobas b 123 Fluid Pack COOX REF 05169992001 200 Product Usage: The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes NAT, K+, iCaWt (ISE), hematocrit (THct), metabolites (GLu, Lac) total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHb, COHb, MetHb), and oxygen saturation (SO2). The cobas b 123 POC system calculates derived parameters. Depending on the equipment configuration of the instrument, the Sensor Cartridge and the Fluid Pack used, the following parameters are measured in human whole blood and QC materials.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code CHL·July 14, 2015

    cobas b 123 Fluid Pack COOX REF 05170036001 400 Product Usage: The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes NAT, K+, iCaWt (ISE), hematocrit (THct), metabolites (GLu, Lac) total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHb, COHb, MetHb), and oxygen saturation (SO2). The cobas b 123 POC system calculates derived parameters. Depending on the equipment configuration of the instrument, the Sensor Cartridge and the Fluid Pack used, the following parameters are measured in human whole blood and QC materials.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code CHL·July 14, 2015

    MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad Stellant CT Injection System (Certegra Workstation), Medrad Mark 7 Arterion" Injection System, or Medrad Mark V ProVis Injection System, Catalog Numbers: Catalog numbers: OCS CEIL (58-S, 58-P, 85-S, 85-P, 100-S, 100-P, 70Si, 97Si), OCS TRACK (58-S, 58-P, 80-S, 80-P), OCS WALL (S, P), OCS (115A, 115CT, 125CT, 125A, 135A, 135CT, 145, 155A, 165A, 115AS, 115CTS), EOC (700, 700S), EOW 700, EOA 700

    FDA Recall
    Terminated ·Bayer Medical Care, Inc.·Product code DXT·December 14, 2018

    DataCare POC is an information management system that provides data management functionality for managing point-of -care testing data.

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code NSX·July 16, 2012

    Siemens RAPIDComm Data Management System. The RAPIDComm Data Management System manages the process of sending and receiving data from Siemens POC devices and hospital systems located in the hospital network,

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics Inc·Product code JQP·May 22, 2014

    Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02

    FDA Recall
    Terminated ·CELLTRION USA INC·Product code QKP·April 1, 2022

    Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later.

    FDA Recall
    Terminated ·Sunquest Information Systems, Inc.·Product code JQP·November 19, 2009

    Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded as Reliability Plus byDrive. The Portable Oxygen Concentrator is intended to deliver concentrated oxygen for adult patients with chronic pulmonary diseases.

    FDA Recall
    Terminated ·Oxus America, Inc.·Product code CAW·January 14, 2013

    BG cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 048103. BG Cartridge are single use, disposable, in vitro diagnostics intended for point of care (POC), professional, use with the IRMA TRUpoint Blood Analysis System.

    FDA Recall
    Terminated ·LifeHealth, LLC·Product code CHL·September 16, 2015

    CC cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 039903. The CC Cartridge are single use, disposable, in vitro diagnostics intended for point of care (POC), professional, use with the IRMA TRUpoint Blood Analysis System.

    FDA Recall
    Terminated ·LifeHealth, LLC·Product code CHL·September 16, 2015

    epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System Product Usage: Usage: epoc Blood Analysis BGEM Test Cards are used with the epoc(R) Blood Analysis System which is a POC testing system

    FDA Recall
    Terminated ·Epocal Inc·Product code CGA·June 28, 2011

    CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device ***The involved units are those with the newest version of a panel PC referred to as POC-127. These panels are identified by serial number. *** The truFreeze is intended for cryogenic destruction of tissue requiring either active or passive venting during surgical procedures. The truFreeze is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant lesions.

    FDA Recall
    Terminated ·Product code GEH·November 10, 2014

    iChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iChem VELOCITY automated urine chemistry system is an in vitro diagnostic deice used to automate the urine chemistry analysis profile using iChem VELOCITY Urine Chemistry Strips. The iChem VELOCITY can be used as a stand alone-system, as well as in an iQ200 Series system, a configuration given the proprietary name iRICELL as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity, semi- quantitative results for glucose, blood, leukocyte esterase, bilirubin, urobilinogen, pH, protein, ketones, and ascorbic acid; and qualitative results for nitrites, color, and clarity. iChem VELOCITY strips are intended for use with the iCHEM VELOCITY analyzer. In particular they are not intended for visual reading. The iChem VELOCITY test strips are not intended for visual reading. The iChem VELOCITY is not intended to be used as a Point of Care (POC) analyzer. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. Tests performed using the iCHEM VELOCITY are intended for clinical laboratory use and in vitro diagnostic use only.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code LJX·December 4, 2017

    RAPIDPoint 500 Blood Gas Analyzer; 10492730, 1069855, 10696857, 10697306 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry including total hemoglobin.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code GKR·July 16, 2018

    RAPIDLab 1265 Blood Gas Analyzer; 110321852, 10470366, 10491395 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry including total hemoglobin.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code GKR·July 16, 2018

    RAPIDLab 1245 Blood Gas Analyzer; 10321844, 10337179, 10491393 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry including total hemoglobin.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code GKR·July 16, 2018

    RAPIDPoint 405 Blood Gas Analyzer; 10282093, 10310464, 10314817, 10317193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, hematocrit, neonatal total bilirubin and full CO-oximetry from a single sample.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code GKR·July 16, 2018