BEUDAMED
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    ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical instrument - Bone Punch

    FDA Enforcement
    Class II ·Terminated·Linvatec Corp. dba ConMed Linvatec·February 13, 2013

    ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical instrument - Bone Punch

    FDA Recall
    Terminated ·Linvatec Corp. dba ConMed Linvatec·Product code LXH·November 15, 2012

    Roche VANC2, Online TDM Vancomycin, for use with the Roche/Hitachi Cobas c 501analyzer; Catalog No.04491050190.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code LEH·April 30, 2007

    ARTHROSCOPY PK L/F 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OJH·July 10, 2015

    PopLok Punch labeled in part: "PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec Biomaterials, Ltd. Hermiankatu 6-8L 33720 Tampere, FINLAND***Rx Only***ConMed Linvatec 11311 Concept Blvd Largo, FL 33773-4908 USA***Made in USA***" Intended Use: Bone Punch.

    FDA Enforcement
    Class II ·Terminated·Linvatec Corp. dba ConMed Linvatec·August 15, 2012

    Roche VALP2, Online TDM Valproic acid , for use with the Roche/Hitachi Cobas c 501 analyzer; Catalog No.04491041190.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code LEG·April 30, 2007

    ARTHROSCOPY PK L/F 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate

    FDA Enforcement
    Class II ·Terminated·Customed, Inc·September 9, 2015

    PopLok Punch labeled in part: "PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec Biomaterials, Ltd. Hermiankatu 6-8L 33720 Tampere, FINLAND***Rx Only***ConMed Linvatec 11311 Concept Blvd Largo, FL 33773-4908 USA***Made in USA***" Intended Use: Bone Punch.

    FDA Recall
    Terminated ·Linvatec Corp. dba ConMed Linvatec·Product code LXH·July 6, 2012

    Cytomics MXP Software, Version 1.0, Part No. 623688.

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code GKL·February 13, 2004

    ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . The ADVIA 120 is a hematology system that utilizes the principles of flow cytometry in order to provide complete blood counts.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics·Product code GKL·June 26, 2013

    US Endoscopy Padlock Clip defect closure system Ref: C910001 The Padlock Clip is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of the gastrointestinal organs.

    FDA Recall
    Terminated ·US Endoscopy Group Inc·Product code PKL·February 4, 2019

    COULTER GEN*S System, Part Number: 6605381, Beckman Coulter, Brea, CA. (Hematology analyzer)

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code GKL·April 18, 2007

    CXP software, Part No. 623560, version 1.0

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code GKL·February 13, 2004

    BD-Retic-Count Reticulocyte Reagent System; Hematology: Used for in vitro diagnostics

    FDA Recall
    Terminated ·Becton, Dickinson and Company, BD Biosciences·Product code GKL·March 18, 2016

    Coulter GEN's The COULTER LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter for In Vitro Diagnostic Use in clinical laboratories. The LH500 Analyzer also provides a semi-automated reticulocyte analysis.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code GKL·January 31, 2011

    ADVIA 2120 systems -Automated Complete Blood Cell and Differential Cell Counter

    FDA Recall
    Terminated ·Bayer Healthcare, LLC (Diagnostics Division)·Product code GKL·March 16, 2006

    CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct immunofluorescence reagent for enumerating percentages of mature human suppressor/cytotoxic (CD8+) lymphocytes in erythrocyte-lysed whole blood or peripheral blood mononuclear cell suspensions.

    FDA Recall
    Terminated ·BD Biosciences, Systems & Reagents·Product code GKL·December 19, 2014

    Critical Care Decontamination System (CCDS) Compatible N95 respirators - Product Usage: Used in decontaminating compatible N95 respirators2 for multiple-user3 reuse by healthcare personnel (HCP)4 to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of Filtering Facepiece Respirators (FFRs) resulting from the Coronavirus Disease 2019 (COVID-19) pandemic.

    FDA Recall
    Terminated ·Battelle Memorial Institute·Product code QKY·August 13, 2020

    GloCyte RBC Reagent - Product Usage: The GloCyte Automated Cell Counter System is intended for use by trained healthcare professionals in clinical laboratories to provide quantitative determination of fluorescence labeled total nucleated cells and erythrocytes in cerebrospinal fluid collected from adult and pediatric patients. The GloCyte Low and High Level Controls are assayed hematology controls designed to monitor the performance of the GloCyte Automated Cell Counter System. Assayed parameters include total nucleated cells and erythrocytes.

    FDA Recall
    Terminated ·Advanced Instruments, LLC·Product code GKL·February 7, 2018

    Cytomics RXP Software, Version 1.0, Part Numbers: 175488 6418489 175260 175261 175262 175263 175264 175265

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code GKL·February 13, 2004