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    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

    Hypoguard, DiaScreen 4pH, Reagent Strips for Urinalysis, 100 strips, Cat. No. D11400.

    FDA Recall
    Terminated ·ARKRAY USA INC.·Product code LJX·March 24, 2010

    NCB Proximal Lateral Tibia, "NCB-PT LAX PROX 3H TIBIA", Various Sizes, Item Nos. 0202261205 0202261207 0202261209 0202261213 0202261305 0202261307 0202261309 0202261313

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code HRS·October 10, 2019

    NCB Proximal Lateral Tibia, "NCB-PT LAX PROX 3H TIBIA", Various Sizes, Item Nos. 0202261205 0202261207 0202261209 0202261213 0202261305 0202261307 0202261309 0202261313

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·November 13, 2019

    The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print and export images when connected with the Centricity PACS infrastructure.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·March 4, 2015

    Access Immunoassay Systems Quality Control Kits, Part Number: 37309 The Access Ostase QC is used for monitoring system performance of the Access Ostase assay.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code JJX·May 10, 2011

    LifeScan brand OneTouch Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603. Testing of Blood Glucose Levels.

    FDA Recall
    Terminated ·Lifescan Inc·Product code JJX·February 25, 2013

    LifeScan brand OneTouch Select Control Solution, Part Number/Model #: 02168902. Testing of Blood Glucose Levels.

    FDA Recall
    Terminated ·Lifescan Inc·Product code JJX·February 25, 2013

    Architect LH MasterCheck (List 6C25-05). An in-vitro diagnostic, consisting of 4 - 2 mL vials of LH MasterCheck, Levels 0, 1, 2 and 3. Manufactured for Abbott Laboratories, Abbott Park, IL 60064. ARCHITECT LH MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the LH assay on the Abbott ARCHITECT i System.

    FDA Recall
    Terminated ·Abbott Laboratories·Product code JJX·September 5, 2008

    Cardiac Marker Control Level 1, List Number 136601-06F12-02; Cardiac Marker Control Level 2, List number 136602/06F13-02; and Cardiac Marker Control Level 3, List number 136603/06F14-02. Used to verify the integrity of newly received i-STAT cTnI cartridges.

    FDA Recall
    Terminated ·Abbott Point Of Care Inc.·Product code JJX·December 17, 2010

    Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme Control Cat. No. 5104 1 x 2.0 mL FOR IN-VITRO DIAGNOSTIC USE Gel Alkaline Phosphatase Isoenzyme Control 20mL 001831 Alkaline Phosphatase Isoenzyme Control is to be used as a qualitative and/or quantitative control to aid in the identification of alkaline Phosphatase isoenzymes by electrophoresis.

    FDA Recall
    Terminated ·Helena Laboratories, Inc.·Product code JJX·November 7, 2016

    Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Part number: 020661 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code JJX·August 7, 2020

    VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics, Inc.·Product code JJX·October 15, 2021

    AmniSure ROM Test, Fetal Membrane Rupture Test for In-Vitro Diagnostic Use, Model: FMRT-1, AmniSure International LLC, Cambridge, MA 02138

    FDA Recall
    Terminated ·AmniSure International LLC·Product code JJX·October 3, 2007

    Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No. 04800840, SMN 10285905 (6 pack - REF)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code JJX·January 10, 2017

    Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No. 04800840, SMN 10285905 (6 pack - REF)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code JJX·January 10, 2017

    4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code JJX·June 22, 2007

    Access Ostase QC, Catalog No. 37309, B83877 Product Usage: The Access Ostase QC is intended for monitoring system performance of the Access Ostase assay.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code JJX·October 24, 2016

    ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT iSystem (reagents, calibrators and instrument), when used for the quantitative determination of human B type natriuretic peptide (BNP) in human EDTA plasma.

    FDA Recall
    Terminated ·Abbott Laboratories·Product code JJX·May 24, 2019

    ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.

    FDA Recall
    Terminated ·Abbott Laboratories·Product code JJX·April 1, 2020