BEUDAMED
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    AXIOM Artis dBA, Model Number 7555357

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019

    AXIOM Artis dBA, Model Number 7555357

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·June 12, 2019

    Axiom Artis dBA, Axiom Artis Modular Angiography X-Ray System, Model number 7555357.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IZI·September 2, 2008

    AXIOM Artis System dBA using software version VB31D with 30x40 cm2 flat detectors. AXIOM Artis is a angiography system developed for single and biplane diagnostic imaging and interventional procedures.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IZI·August 25, 2008

    Custom Assembly, Custom FCFFM x/8.2 cm Tubing Extension, Model Number: FCA026-001, Manufactured by: Value Plastics dba Nordson MEDICAL, 805 West 71st Street, Loveland, CO 80538, packaged in Bags consisting of 100, 500 or 1,000 stopcocks.

    FDA Enforcement
    Class II ·Terminated·Value Plastics, Inc.·March 16, 2016

    OsteoStim Cervical Allograft (Lordotic Cervical Spacer) H. 7mm; W. 14mm; L. 10mm., Catalog Number: 45-5537 and Catalog Number : LGAL906, Distributed by EBI. (dba Biomet Spine, Biomet Trauma, Biomet Bracing, Biomet Osteobiologics) Parsippany, New Jersey 07054

    FDA Recall
    Terminated ·Product code MQV·October 23, 2007

    Custom Assembly, Custom FCFFM x/8.2 cm Tubing Extension, Model Number: FCA026-001, Manufactured by: Value Plastics dba Nordson MEDICAL, 805 West 71st Street, Loveland, CO 80538, packaged in Bags consisting of 100, 500 or 1,000 stopcocks.

    FDA Recall
    Terminated ·Value Plastics, Inc.·Product code FMG·December 18, 2015

    ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement: Calibrator-1206 U/mL, Positive Control-228 - 532 U/mL, and Negative Control-<120 U/mL; Manufactured by Innominata dba GenBio for Bio-Rad. The kit is used as an aid in diagnosis of Lyme disease.

    FDA Enforcement
    Class II ·Terminated·Innominata Dba Genbio·March 20, 2013

    ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement: Calibrator-1206 U/mL, Positive Control-228 - 532 U/mL, and Negative Control-<120 U/mL; Manufactured by Innominata dba GenBio for Bio-Rad. The kit is used as an aid in diagnosis of Lyme disease.

    FDA Recall
    Terminated ·Innominata Dba Genbio·Product code LSR·February 11, 2013

    EPIFLO; Transdermal continuous oxygen therapy device; single use; disposable medical device. Model Number EPIFLO-15. Mfr.By: Neogenix, LLC, dba Ogenix, 3401 Enterprise Pkwy, Suite 340, Beachwood, OH 44122. The EPIFLO System is intended to provide topical oxygen to treat 1.) skin ulcerations due to diabetes, venous stasis, post-surgical infections and gangrenous lesions 2.) Decubitus ulcers 3.) amputations/infected stumps 4.) skin grafts 5.) burns 6.) frostbite.

    FDA Recall
    Terminated ·Ogenix Corporation·Product code KPJ·April 16, 2012

    NOW Legionella Urinary Antigen Test. 22 test kit. For In Vitro Diagnostic Use Product Code: 852-000

    FDA Recall
    Terminated ·Inverness Medical Professional Diagnostics·Product code MJH·September 29, 2006

    Tina-quant Complement C4 ver.2, Catalog 05991994190

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code DBI·August 27, 2020

    ST-AIA PACK Fer; Part Number: 025253 Assay, Anemia

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code DBF·March 5, 2018

    ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 06567787 (6 pack)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code DBF·October 9, 2012

    ARCHITECT Ferritin Reagent; in vitro diagnostic; list numbers 6C11-20 (4 x 100 tests), 6C11-25 (1 x 100 tests) and 6C11-30 (4 x 500 tests); Abbott Laboratories, Abbott Park, IL 60064 USA

    FDA Recall
    Terminated ·Abbott Laboratories MPG·Product code DBF·June 6, 2006

    Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of ferritin in human serum and plasma on the Alinity i analyzer.

    FDA Recall
    Terminated ·Abbott Ireland Diagnostics Division Lisnamuck Co. Longford Ireland·Product code DBF·November 21, 2018

    ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 03439230 (2 pack)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code DBF·October 9, 2012

    C4 is an in vitro diagnostic assay for the quantitative determination of C4 in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 604 nm, which correlates with the concentration of C4 in the sample.

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code DBI·May 16, 2018

    ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 672182005 (US Reference 6 pack)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code DBF·October 9, 2012

    Dimension Vista Ferritin (FERR) Flex reagent cartridge

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code DBF·March 21, 2017