BEUDAMED
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    Howmedica Osteonics Corp., Scorpio NRG Femoral Size 7 Right; Knee prosthesis (Stryker France). Product Code: 814407R. Mahwah, NJ

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code JWH·August 20, 2007

    i-STAT PT/INR Cartridge Abbott Point of Care, Princeton, NJ

    FDA Recall
    Terminated ·Abbott Point of Care Inc.·Product code GJS·May 5, 2010

    BD Vacutainer Urine Complete Kit with UA Preservative Tube and C&S Preservative Tube for Midstream Specimens PLUS Plastic, Sterile Cup and Tube Interiors. Store at 4-25 degrees C. For In Vitro Diagnostic Use. Becton Dickinson and Company, Franklin Lakes, NJ.

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code JSM·October 12, 2009

    BD Vacutainer Urine Complete Kit with UA Tube and S&C Preservative Tube for Midstream specimens; Plus Plastic - Sterile Cup and Tube interiors. Store at 4-25 degrees C. Kit contains Sterile Screw CAP Collection Cup with integrated Transfer Device and 8.0 mL, 16/x100 mm PLUS Plastic Conical Tube for Urinalysis and 4.0 mL 13x75mm Plus Plastic C&C Preservative tube and Castile Soap Towelettes; Becton Dickinson and Company, Franklin Lakes, NJ

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code JSM·October 12, 2009

    Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)

    FDA Enforcement
    Class II ·Terminated·Abaxis Inc·June 24, 2020

    Anti-dsDNA [125I] Radiobinding Assay Kit. For In-Vitro Diagnostic Use Catalog Number: NEA 103

    FDA Recall
    Terminated ·Perkinelmer Life Sciences, Inc.·Product code DHN·July 21, 2003

    Vein Kit - No Introducer TVS4027-NI(A convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    RELISA ENA Multiparameter Antibody Screening test, enzyme immunoassay test system, manufactured by Immuno Concepts N.A. Ltd., Sacramento, CA.

    FDA Recall
    Terminated ·Immuno Concepts Inc·Product code LLL·November 25, 2008

    COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological

    FDA Enforcement
    Class II ·Terminated·Iba Dosimetry Gmbh·March 4, 2015

    ANA Fluorescent Test System and ANA Colorzyme Test System, Sub assembly catalog number SA 2013, Kit Catalog Numbers, 2000, 2002, 2003, 2004, 2005, 2100, 2200, 4000, 4200, 8024.1, and 8060, manufactured by Immuno Concepts N.A. Ltd, Sacramento, CA. The device is used in the screening and titration of circulating antinuclear antibodies by means of an immunofluoresence test. Products are to be used as an aid in the detection of antibodies associated with systemic rheumatic disease.

    FDA Recall
    Terminated ·Immuno Concepts Inc·Product code DHN·December 4, 2008

    Lodox Statscan digital radiographic system.

    FDA Recall
    Terminated ·Lodox Na Llc·May 10, 2004

    BC Thrombin Reagent . Thrombin Time Test

    FDA Recall
    Terminated ·Dade Behring Inc. Rte 896, Glasgow Business Community·Product code GJA·July 21, 2004

    BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and BC Thrombin Reagent Kit Lot Number 47184; UDI -008427680131024718420190221; BC Thrombin Reagent; Test, Thrombin Time Product Usage: For in vitro diagnostic use. Reagent for the quantitative determination of the thrombin time in citrated human plasma.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics·Product code GJA·October 17, 2017

    MDA Fibriquik, bioMeriux, Inc., Box 15969, Durham, North Carolina 27704-0969

    FDA Recall
    Terminated ·bioMerieux·Product code GJA·August 20, 2004

    BACTEC(tm) MGIT(tm) 5-Tube Spare AST Set Carrier, Bag of 3, Catalog 445943. ***Becton, Dickinson and Company 7 Loveton Circle Sparks, Maryland 21152*** The BACTEC MGIT AST system is a rapid qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture, to streptomycin, isoniazid, rifampin, ethambutol, and pyrazinamide. The routine AST set consists of a Growth Control tube and one tube for each drug, as well as a barcoded tube carrier that holds the set. The barcode provides set size and identification. A tube rack capable of holding up to 55 AST tubes in various set combinations is available for tube setup and transport. (Large or small AST carrier sets can be placed in the rack also.) The MGIT AST system is based on growth of the Mycobacterium tuberculosis strain under test as measured by the instrument. AST sets are entered into the BACTEC MGIT 960 instrument and are tested automatically. Analysis of fluorescence in a drug containing tube is compared to the fluorescence of the Growth Control tube to determine susceptibility results.

    FDA Recall
    Terminated ·Becton Dickinson & Co. BD Diagnostic Systems·Product code MJA·August 31, 2010

    BACTEC(tm) MGIT(tm) AST Label Spares, Catalog 445959. Kit contains Contains 5 each of the 5-Tube and 2-Tube Barcoded Labels. ***Becton, Dickinson and Company 7 Loveton Circle Sparks, Maryland 21152*** The BACTEC MGIT AST system is a rapid qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture, to streptomycin, isoniazid, rifampin, ethambutol, and pyrazinamide. The routine AST set consists of a Growth Control tube and one tube for each drug, as well as a barcoded tube carrier that holds the set. The barcode provides set size and identification. A tube rack capable of holding up to 55 AST tubes in various set combinations is available for tube setup and transport. (Large or small AST carrier sets can be placed in the rack also.) The MGIT AST system is based on growth of the Mycobacterium tuberculosis strain under test as measured by the instrument. AST sets are entered into the BACTEC MGIT 960 instrument and are tested automatically. Analysis of fluorescence in a drug containing tube is compared to the fluorescence of the Growth Control tube to determine susceptibility results.

    FDA Recall
    Terminated ·Becton Dickinson & Co. BD Diagnostic Systems·Product code MJA·August 31, 2010

    Fibriquik, bioMeriux, Inc., Box 15969, Durham, North Carolina 27704-0969

    FDA Recall
    Terminated ·bioMerieux·Product code GJA·August 20, 2004

    Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of Ethyl Vinyl Olefin (EVO) and contains no BPA or latex. The bag can be supplied with tubing sets that can include, but are not limited to, the following components: EVA/PVC coextruded tubing, PVC tubing, Yconnectors, needle-free valves, female luers, male luers and/or caps

    FDA Recall
    Terminated ·OriGen Biomedical, Inc.·Product code KJA·January 28, 2021

    BACTEC(tm) MGIT(tm) 2-Tube Spare AST Set Carrier, Bag of 3, Catalog 445946. ***Becton, Dickinson and Company, 7 Loveton Circle Sparks, Maryland 21152*** The BACTEC MGIT AST system is a rapid qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture, to streptomycin, isoniazid, rifampin, ethambutol, and pyrazinamide. The routine AST set consists of a Growth Control tube and one tube for each drug, as well as a barcoded tube carrier that holds the set. The barcode provides set size and identification. A tube rack capable of holding up to 55 AST tubes in various set combinations is available for tube setup and transport. (Large or small AST carrier sets can be placed in the rack also.) The MGIT AST system is based on growth of the Mycobacterium tuberculosis strain under test as measured by the instrument. AST sets are entered into the BACTEC MGIT 960 instrument and are tested automatically. Analysis of fluorescence in a drug containing tube is compared to the fluorescence of the Growth Control tube to determine susceptibility results.

    FDA Recall
    Terminated ·Becton Dickinson & Co. BD Diagnostic Systems·Product code MJA·August 31, 2010

    BACTEC(tm) MGIT(tm) AST Starter Kit, Catalog 445941. Kit contains 16 each of the 5-Tube and 2-Tube Set Carriers. ***Becton, Dickinson and Company 7 Loveton Circle Sparks, Maryland 21152*** The BACTEC MGIT AST system is a rapid qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture, to streptomycin, isoniazid, rifampin, ethambutol, and pyrazinamide. The routine AST set consists of a Growth Control tube and one tube for each drug, as well as a barcoded tube carrier that holds the set. The barcode provides set size and identification. A tube rack capable of holding up to 55 AST tubes in various set combinations is available for tube setup and transport. (Large or small AST carrier sets can be placed in the rack also.) The MGIT AST system is based on growth of the Mycobacterium tuberculosis strain under test as measured by the instrument. AST sets are entered into the BACTEC MGIT 960 instrument and are tested automatically. Analysis of fluorescence in a drug containing tube is compared to the fluorescence of the Growth Control tube to determine susceptibility results.

    FDA Recall
    Terminated ·Becton Dickinson & Co. BD Diagnostic Systems·Product code MJA·August 31, 2010