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    Urinary Tract Infection Test

    FDA Recall
    Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code LJX·November 3, 2025

    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

    One Step UTI in vitro diagnostic test REF: 3374

    FDA Recall
    Open, Classified ·DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)·Product code LJX·April 2, 2026

    LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in-1 Urinalysis Reagent Strip; JNW Direct 4-in-1 UTl Urinalysis Test Strips; Urinify STRENGTH; Urinify ESSENTIAL, Urinify Urinary Tract Infection (UTI)

    FDA Recall
    Open, Classified ·Changchun Wancheng Bio-Electron Co., Ltd. 2336, Tianwei Road Beihu Science and Technology Development Zone Changchun China·Product code LJX·November 22, 2025

    IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code MHX·June 28, 2024

    IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866062. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code MHX·June 28, 2024

    IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866066. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code MHX·June 28, 2024

    IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code MHX·June 28, 2024

    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

    Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,

    FDA Recall
    Open, Classified ·Philips Ultrasound, LLC·Product code IYN·October 31, 2025

    a. Skin Adhesive McKesson LiquiBand Exceed 0.4 mL Liquid Dome Applicator Tip 2-Octyl Cyanoacrylate. Model Number: 122-LBXS. b. Skin Adhesive McKesson LiquiBand Exceed 0.8 mL Liquid Precision and Dome Applicator Tip 2-Octyl Cyanoacrylate. Ref: 122-LBX. c. ADVANCED MEDICAL SOLUTIONS McKesson ADHESIVE, LIQUIBAND TISSUE FLOW SM TIP 0.5ML (12/BX 6BX/CS). Catalog #122-LFC

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code MPN·May 25, 2022

    The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range with an intended use of disinfecting surfaces.

    FDA Recall
    Open, Classified ·MAX LUX CORP 03e 01 01 Yangxi Indust Ry Zone Yangjiangyangjiang China·Product code RHP·October 26, 2021

    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

    Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive Level / Negative Level 2 X 4 mL

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code JJX·January 9, 2024

    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

    ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10310308

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JJX·January 9, 2023