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    Filters FDA Recall × Status: Terminated × Clear all

    C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc.·Product code IYE·June 17, 2014

    QIAGEN artus CMV RG PCR ASR (24) (Catalog number 4503223) Product Usage: The artus CMV RG PCR ASR is designed to detect and to quantify nucleic acid specific to human cytomegalovirus (CMV) using real-time PCR technology (PCR) in the Rotor-Gene 2000/3000 (RG).

    FDA Recall
    Terminated ·QIAGEN Gaithersburg, Inc.·Product code LKQ·January 30, 2013

    Varian brand Clinac, Accelerator, Linear, Medical charged-particle radiation therapy system: Model: High Energy Clinacs with one or more of the following options: -- BrainLAB micro MLC, -- 6MV SRS photon beam, -- Fine Beam Isocenter Accuracy, -- Stereotactic motion disable. ----Product is manufactured and distributed by Varian Medical Systems, Palo Alto, CA

    FDA Recall
    Terminated ·Varian Medical Systems Inc·Product code IYE·September 10, 2007

    IMMULITE 2000/IMMULITE 2000XPi Systems CMM CMV IgM Assay, REF/Catalog Number L2KCM2(D) - 200 tests (US), SMN 10370302 (US), UDI 00630414985725 (US); and REF/Catalog Number L2KCM2 - 200 tests (OUS), SMN 10371320 (OUS), UDI 00630414961163 (OUS); IVD --- Siemens Healthcare Diagnostics Products Ltd., Llanberis, Gwynedd, LL55 4EL UK For in vitro diagnostic use with IMMULITE 2000 analyzers for the qualitative detection of IgM antibodies to cytomegalovirus (CMV) in human serum or plasma (EDTA or heparinized), as an aid in the diagnosis of current and recent CMV infection in individuals with signs and symptoms of CMV infection or clinical suspicion of CMV infection. This assay is not FDA cleared or approved for use in testing (screening) blood or plasma donors, neonatal screening, or for use at point-of-care facilities.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code LKQ·August 30, 2016

    VIDAS CMV IgG Assay

    FDA Recall
    Terminated ·bioMerieux·Product code LFZ·June 9, 2004

    VIDAS CMV IgM 30 Tests

    FDA Recall
    Terminated ·Biomerieux Inc·Product code LKQ·March 16, 2021

    Diamedix Is-CMV IgG Test Kit

    FDA Recall
    Terminated ·Diamedix Corporation·Product code LFZ·March 26, 2015

    QIAGEN artus CMV RG PCR ASR (96) (Catalog number 4503225) Product Usage: Test is intended for use in the detection and quantitation of human cytomegalovirus (CMV) specific DNA, as part of an in house validated real-time PCR assay. One service package containing the handbook.

    FDA Recall
    Terminated ·QIAGEN Gaithersburg, Inc.·Product code LKQ·January 30, 2013

    VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.

    FDA Recall
    Terminated ·bioMerieux, Inc.·Product code LKQ·February 9, 2022

    SeraQuest***CMV IgM TEST SET For the detection of CMV IgM Antibodies 96 Test Set Cat. No. 01-150 Store 2-8 C For In Vitro Diagnostic Use***Contents: 1 96 wells bag with holder, 1 Negative Control*, 1 Positive Control*, 1 Substrate, 1 Stop Solution, 1 Conjugate*, 1 Calibrator 1*, 1 Calibrator 2*, 1 Diluent for Specimen*, 1 Wash Concentrate*, *Contains Sodium Azide Lot No. E1700 Doral, FL 33122 USA Exp. Date: May 11. BIORAD***CMV IgM EIA For the detection of CMV IgM Antibodies Xn-HARMFUL Cat. No. 25178 96 Test Set Store 2-8 C ID: grey For In Vitro Diagnostic Use*** Contents: I CMV IgM Microplate (96 wells), 1 Negative Control* (0.6 mL), 1 Positive Control (0.6 mL), 1 Substrate (12 mL), 1 Stop Reagent (12 mL), 2 Conjugate* (12 mL), 1 Calibrator 1* (0.6 mL), 1 Calibrator 2* (0.6 mL) , 1 Diluent* (25 mL), 1 Wash Concentrate* (30 mL), *0.1% Sodium Azide Lot No. E1700 Distributed by: Bio-Rad Laboratories-Redmond, WA 98052.

    FDA Recall
    Terminated ·Quest International, Inc.·Product code LKQ·September 28, 2010

    AxSYM CMV IgG Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; The AxSYM CMV IgG assay is a Microparticle Enzyme Immunoassay (MEIA) for the semi-quantitative measurement of IgG antibodies to cytomegalovirus in human serum and plasma (EDTA, heparin or sodium citrate) as an indication of past or current infection with cytomegalovirus; list 4B47-20

    FDA Recall
    Terminated ·Abbott Laboratories·Product code LFZ·January 19, 2009

    IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D) - 100 tests (US), Siemens Material Number (SMN) 10370301 (US), Unique Device Identification Number (UDI) 00630414985718 (US); and REF/Catalog Number LKCM1 - 100 tests (OUS); SMN 10381296 (OUS), UDI 00630414963747 (OUS); IVD --- Made in UK Siemens Healthcare Diagnostics Products Ltd., Glyn Rhonwy, Llanberis, Gwynedd, LL55 4EL UK For in vitro diagnostic use with the IMMULITE Systems Analyzers for the qualitative detection of IgM antibodies to Cytomegalovirus (CMV) in human serum or plasma (EDTA or heparinized), as an aid in the determination of an acute CMV infection.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code LKQ·August 30, 2016

    Temporary Pacing Wire, BIPOLAR, Models BM, V, VE and VF, Rx Only, STERILE/EO, Single use only -- Mce (MEDICAL CONCEPTS EUROPE) --- Manufacturer ECM B.V. Oost-Om 54, P.O. Box 53, NL 5420 AB GEMERT --- Shipping or Unit Package: 20 individual units packaged per box with 6 boxes per case. --- Device Classification Name: Electrode, pacemaker, temporary. ---The device is supplied sterile and intended for single use. Used to pace the heart during or after open heart surgery. The electrodes are placed on the heart; the other end of the pacing wire is inserted through the skin of the patient with a thoracic needle. The thoracic needle can snap-off at the end where the pacing wire is attached, after snap-off the remaining pins are connected to an external pacemaker. For temporary atrial and ventrical pacing and sensing for contemplated implant duration of 7 days or less.

    FDA Recall
    Terminated ·European Custom Manufacturing B.V. Oost-Om 54 Gemert Netherlands·Product code LDF·April 18, 2011

    Cytomegalovirus (CMV) IgG ELISA Test System, In-Vitro Diagnostic, manufactured by Zeus Scientific, Inc., Raritan, NJ.

    FDA Recall
    Terminated ·Zeus Scientific Inc·Product code LFZ·June 12, 2003

    Premier CMV IgG Elisa Kits, EIA diagnostic test kits, 96 tests per kit, Catalog Numbers: 620096 and 9Z9501G.

    FDA Recall
    Terminated ·Meridian Bioscience Inc·Product code LFZ·June 18, 2003

    AxSYM CMV IgM Reagent Pack; list 05C78; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories·Product code LKQ·April 23, 2007

    AxSYM CMV IgG Reagent Pack; list 04B47; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories·Product code LFZ·April 23, 2007

    Digene Hybrid Capture System CMV DNA Test (version 2.0), packaged in a cardboard box containing test reagents for performing 60 tests. Digene Catalog #4403-2003.

    FDA Recall
    Terminated ·Digene Corp·Product code LSO·May 28, 2004

    PML --IDS Rapid NH QC Set- Quality Control kit for culture media. Product label includes LyfoCults IVD , Lot # 134-1 Exp 02AUG2008. PML Micrcobiologicals 27120 SW 95th Avenue Wilsonville, Oregon 97070

    FDA Recall
    Terminated ·PML, Inc. dba Pml Microbiologicals Inc.·Product code JTR·October 15, 2007

    PML -- Vitek NH ID Card (NHI) Set - Quality Control kit for culture media. Each kit includes a 5 pack of LyfoCults Haemophilus parainfluenzae - Lot # 185-1 Exp 13AUG2008. PML Micrcobiologicals, 27120 SW 95th Avenue, Wilsonville, Oregon 97070

    FDA Recall
    Terminated ·PML, Inc. dba Pml Microbiologicals Inc.·Product code JTR·October 15, 2007