BEUDAMED
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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

    Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profile Prime ABG Analyzer PN 53655 Stat Profile Prime ABG Analyzer with Scanner PN 52856 Stat Profile Prime CCS Analyzer PN 53656 Stat Profile Prime CCS Analyzer with Scanner PN 53657 Stat Profile Prime CCS Comp Analyzer with Scanner PN 52857 Stat Profile Prime CCS Comp Analyzer Blood Gas/Electrolyte/Metabolite/CO-Oximetry Analyzer

    FDA Recall
    Terminated ·Nova Biomedical Corporation·Product code CHL·June 19, 2017

    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

    ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 mL QC2, 1 QC VALUE CARD, IVD, Rx Only, UDI: (01)15099590742737;

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code QKP·July 1, 2021

    Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements. Available in packs of 2 or 6.

    FDA Recall
    Terminated ·Microbiologics Inc·Product code JTR·October 8, 2020

    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

    Immulite 2500 Automated Immunoassay Analyzer, Human chorionic gonadotrpin (HCG) test system.

    FDA Recall
    Terminated ·DPC Cirrus·Product code DHA·October 29, 2004

    Immulite 2000. Immunoassay system. Software version 2.6 was to be uploaded on systems running 2.5b software.

    FDA Recall
    Terminated ·DPC Cirrus·Product code JJE·June 13, 2003

    IMMULITE 2000. An Automated, Quantitative Immunoassay Analyzer for In Vitro Diagnostic Use. Manufactured by DPC Cirrus Inc., Flanders, NJ 07836

    FDA Recall
    Terminated ·DPC Cirrus·Product code JJE·April 22, 2005

    ADVIA Centaur Folate (500 tests), REF SMN 10331250, Cat No. 00203473 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code CGN·July 25, 2013

    ADVIA Centaur Folate (100 Tests), SMN 10310308, Cat No. 06367974 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code CGN·July 25, 2013

    ADVIA Centaur Folate (2500 tests), REF SMN 10340209, Cat No. 09132781 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code CGN·July 25, 2013

    ADVIA Centaur Folate (500 Tests) SMN 10325366, Cat No. 06891541 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code CGN·July 25, 2013

    Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Dispense with software versions 3.5.1 and 3.6. In vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric, and integrated ion-selective multisensory technology for clinical use.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JJE·June 19, 2013

    ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code QKO·December 30, 2020

    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

    Apolipoprotein B is an in vitro diagnostic assay for the quantitative determination of apolipoprotein B in human serum or plasma. Antibodies to apolipoprotein B combine with apolipoprotein B in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 604 nm, is directly proportional to the concentration of apolipoprotein B in the sample.

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

    IgE Calibrator Series

    FDA Recall
    Terminated ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code DGC·September 7, 2016