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    Filters FDA Recall × Status: Terminated × Clear all

    AXIOM Artis dBC, Model Number 5917054

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

    AXIOM Artis dBC, Model Number 7728392

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

    Axiom Artis dBC, Axiom Artis Modular Angiography X-Ray System, Model number 7728392.

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

    Axiom Artis dBC-M, Axiom Artis Modular Angiography X-Ray System, Model number 5917054.

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

    Artis systems - Product Usage: an angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Model Numbers: System Material # AXIOM Artis FC 05904433; AXIOM Artis FA 05904441; AXIOM Artis MP 05904466; AXIOM Artis BC 05904649; AXIOM Artis BA 05904656; AXIOM Artis dBC Mag. Nav. 05917054; AXIOM Artis TA 07007755; AXIOM Artis dTA 07008605; AXIOM Artis dFC 07412807; AXIOM Artis dTC 07413078; AXIOM Artis dBA 07555357; AXIOM Artis dMP 07555365; AXIOM Artis dFA 07555373; AXIOM Artis dFC Mag. Nav. 07727717; AXIOM Artis TC 07728350; AXIOM Artis dBC 07728392; Artis zee floor 10094135; Artis zee ceiling 10094137; Artis zee MP 10094139; Artis zee biplane 10094141; Artis zee floor MN 10094142; Artis zee biplane MN 10094143; Artis Q floor 10848280; Artis Q ceiling 10848281; Artis Q biplane 10848282; Artis Q.zen floor 10848353; Artis Q.zen ceiling 10848354; Artis Q.zen biplane 10848355.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·March 30, 2021

    Anspach Carbide Cutting Burrs & Drums: 2MM Carbide Fluted Ball, Extended part # S-2B-C and 7MM Carbide Fluted Ball part # S-7B-C Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBE·December 17, 2013

    Anspach Carbide Cutting Burrs: 1.5MMx7.5MM Cylindrical Carbide Drum part # S-15DRMC-L, 1MM Carbide Fluted ball, Extended part # S-1B-C, 1MM Carbide Fluted ball part # S-SB-C, 2MM Carbide Fluted ball part # S-2SB-C, 3MM Carbide Fluted ball Extended part # S-3B-C, 3MM Carbide Fluted ball part # S-3SB-C, 4MM Carbide Fluted ball part # S-4B-C, 4MM Carbide Fluted ball Extended 27MM part # S-4BL-C, 5MM Carbide Fluted ball part # S-5B-C, and 6MM Carbide Fluted ball part # S-6B-C. Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBE·December 17, 2013

    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

    Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.

    FDA Recall
    Terminated ·Accriva Diagnostics Inc., dba ITC, dba Accumetrics·Product code JPA·April 22, 2016

    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

    A-dec Decade Plus 1221 Dental Chair This chair is used for positioning dental patient prior to and during dental treatment.

    FDA Recall
    Terminated ·A-Dec Inc·Product code KLC·April 1, 2009

    Enterprise 9000 Bed; an AC-powered adjustable hospital bed with built-in electronic weigh scale, patient bed exit alarm, and under bed anti-entrapment system; ArjoHuntleigh AB, Eslov, Sweden; Models 9000, 9600, 9700 and 9800 General medicine, general and specialist surgery, care of the elderly, HDU, ITU, coronary care and oncology. The bed is appropriate for high dependency patients who pose a movement and handling risk and/or whose clinical condition requires that they are positioned with the minimal physical handling.

    FDA Recall
    Terminated ·Arjo, Inc. dba ArjoHuntleigh·Product code FNL·November 16, 2012