BEUDAMED
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    BACTEC

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS·Product code JTA·September 6, 1994

    ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Other ·BECKMAN COULTER, INC.·Product code MMI·August 23, 2005

    SYNCHRON LX I 725 CLINICAL SYSTEM

    FDA Adverse Event
    Other ·BECKMAN COULTER, INC.·Product code JJE·July 13, 2005

    DADE ACTIN FS ACTIVATED PTT REAGENT

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code GGW·April 20, 2017

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code MMI·October 14, 2011

    BD FACS¿ SAMPLE PREP ASSISTANT III

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code PER·November 14, 2023

    BD FACSCANTO II CYTOMETER 4/2 SYSTEM IVD

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·October 31, 2023

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code MMI·March 5, 2012

    ACCESS 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Other ·BECKMAN COULTER, INC.·Product code JJE·August 29, 2005

    BD FACS¿ LWA

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code JQW·November 3, 2023

    BD FACSCANTO¿ II SYSTEM W/FLUIDICS CART

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code OYE·October 20, 2023

    BD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, used in conjunction with the appropriate extraction kits and reagents is capable of automated amplification and detection of target nucleic acid sequences for use in clinical, industrial, and research settings.

    FDA Recall
    Terminated ·Becton Dickinson & Co. BD Diagnostic Systems·Product code NJR·May 31, 2013

    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

    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

    BD ProbeTec" CT/GC/AC Reagent Pack, catalog #440450, labeled in part ***Becton Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152*** The BD ProbeTec" ET Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assays, when tested with the BD ProbeTec ET System, use Strand Displacement Amplification (SDA) technology for the direct, qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in endocervical swabs, male urethral swabs, and in female and male urine specimens as evidence of infection with C. trachomatis, N. gonorrhoeae, or of co-infection with both C. trachomatis and N. gonorrhoeae. Specimens may be from symptomatic or asymptomatic females and males. A separate Amplification Control is an option for inhibition testing (BD ProbeTec ET CT/GC/AC Reagent Pack). The BD ProbeTec ET CT/GC assays may be performed using either the BD ProbeTec ET System or a combination of the BD ProbeTec ET System and BD Viper" instrument.

    FDA Recall
    Terminated ·Becton Dickinson & Co. BD Diagnostic Systems·Product code MKZ·September 29, 2010