BEUDAMED
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    Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).

    FDA Enforcement
    Class II ·Terminated·Pro-Dex Inc·March 23, 2016

    Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).

    FDA Enforcement
    Class II ·Terminated·Pro-Dex Inc·March 23, 2016

    Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).

    FDA Recall
    Terminated ·Pro-Dex Inc·Product code MOQ·December 23, 2015

    Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).

    FDA Recall
    Terminated ·Pro-Dex Inc·Product code MOQ·December 23, 2015

    Synchron Phenobarbital (PHE) Reagent, P/N 469785, Classification Product Code: KLT. Subsequent Product Codes: DIP, KLS, LCD, LCQ, LCR, LFN. PHE reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems Drug Calibrator 1, is intended for quantitative determination of Phenobarbital concentration in human serum or plasma.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code DKB·August 11, 2009

    Synchron Phenobarbital (PHE) Drug Calibrator 1, P/N 469600, Classification Product Code: KLT. Subsequent Product Codes: DIP, KLS, LCD, LCQ, LCR, LFN. The Beckman Coulter SYNCHRON Systems DRUG CALIBRATOR 1, when used in conjunction with SYNCHRON reagents, is intended for use on the SYNCHRON Systems for the calibration of Carbamazepine, Phenobarbital, Phenytoin, Theophylline, and Valproic Acid.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code DLZ·August 11, 2009

    Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071) The THEO method is an in vitro diagnostic test for the quantitative measurement of Theophylline in human serum and plasma on the Dimension Vista(R) system.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code KLS·August 9, 2012

    Access Immunoassay System Technical Update 03.1, Part number 387851, Software version 3.29

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code KLS·June 18, 2003

    Syva EMIT 2000 Theophylline Product Usage: The Syva Emit 2000 Theophylline Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code KLS·November 27, 2017

    VITROS Chemistry Products TRIG Slides packaged as 300 slides/pack catalog number 1336544 and packaged as 90 slides/pack catalog number 8329930 VITROS TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code KLS·June 12, 2013

    VITROS Chemistry Products THEO Slides packaged as 300 slides/pack catalog number 8301764 and packaged as 90 slides/pack catalog number 1307164 VITROS THEO Slides quantitatively measure theophylline (THEO) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code KLS·June 12, 2013

    Syva EMIT 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code KLS·June 17, 2016

    ADVIA Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent is for in vitro diagnostic use in the quantitative analysis of theophylline in human serum or plasma on the ADVIA Chemistry Systems. Copies of IFUs included in submission.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code KLS·June 17, 2016

    Siemens Healthcare ADVIA Centaur Theophylline 2 (THE02) 250 Test 08838753 50 Test 03009619 Intended Use For in vitro diagnostic use in the quantitative determination of theophylline in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code KLS·November 14, 2012

    Zoll E Series BLS Defibrillator/Pacemaker/Monitor Software versions 7.10 and 7.11 The product is used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In addition, the product may be used in synchronized mode to terminate certain atrial and ventricular tachycardias and other arrhythmias resistant to drug therapy. The E Series may be used for cardiac pacing in conscious or unconscious patients for up to a few hours duration as an alternative to endocardial stimulation. The E Series may be used for the monitoring a patients electrocardiogram (ECG).

    FDA Recall
    Terminated ·ZOLL Medical Corporation·Product code MKJ·April 21, 2011

    CLS Stem

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code LZO·September 4, 2012

    Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02, Rx Only, Sterile EO - Product Usage: used with the Tranberg MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue.

    FDA Recall
    Terminated ·CLINICAL LASERTHERMIA SYSTEMS AB Scheelevagen·Product code GEX·April 1, 2021

    Tranberg MR Cannula, REF: 4013-05, Rx Only, Sterile EO - Product Usage: used with the Tranberg MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue.

    FDA Recall
    Terminated ·CLINICAL LASERTHERMIA SYSTEMS AB Scheelevagen·Product code GAH·April 1, 2021

    Tranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, Rx Only, Sterile EO - Product Usage: used with the Tranberg MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue.

    FDA Recall
    Terminated ·CLINICAL LASERTHERMIA SYSTEMS AB Scheelevagen·Product code GEA·April 1, 2021

    CLS Stem

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·November 14, 2012