BEUDAMED
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    BD GeneOhm MRSA 200 ct, Catalog #441242. IDI-MRSA assay is a qualitative in vitro diagnostic test for the direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in healthcare settings. The test performed on the Smart Cycler instrument with a nasal swab specimen from patients at risk for colonization, utilizes polymerase chain reaction (PCR) for the amplification of MRSA DNA and fluorgenic target-specific hybridization probes for the detection of amplified DNA. IDI-MRSA assay is not intended to diagnose MRSA infections nor to guide or monitor treatment for MRSA infections. Concomitant cultures are necessary only to recover organisms for epidemiological typing or for further susceptibility testing.

    FDA Recall
    Terminated ·BD Diagnostics (GeneOhm Sciences, Inc)·Product code NQX·July 21, 2008

    BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics.

    FDA Recall
    Terminated ·BD Biosciences, Systems & Reagents·Product code OYE·June 6, 2014

    Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytometric immunophenotyping of hematologic disorders.

    FDA Recall
    Terminated ·BD Biosciences, Systems & Reagents·Product code MVU·December 19, 2014

    BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II systems. The beads are run with BD FACSCanto clinical software. This system provides application specific setup, including automated compensation and cytometer quality control (QC) with minimal user intervention.

    FDA Recall
    Terminated ·BD Biosciences, Systems & Reagents·Product code GKZ·June 29, 2012

    BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto II, BD LSR II, BD LSRFortessa,BD FACSAria, BD FACSAria II, BD FACSAria Ill, BD lnflux, BD FACSArray,BD Pathway 855, BD Pathway 435 and all SORP instruments. BD Biosciences Flow cytometers for the enumeration of tissue and biological fluid samples such as blood and blood components.

    FDA Recall
    Terminated ·BD Biosciences, Systems & Reagents·Product code GKZ·June 15, 2015

    BD DifcoTM Neisseria Meningitidis Antisera Group Y 228811, 1mL, in vials, which were labeled in part, 8019456 6250890 N. MEN. GP Y UNLABELED LYOPH, Becton, Dickinson and Company, Sparks, MD 21152. The product is packaged in 1 vial units. For use in slide agglutination tests for serotyping Neisseria Meningitidis.

    FDA Recall
    Terminated ·BD Diagnostic Systems Lee Laboratories·Product code GTJ·September 6, 2007

    BD GeneOhm MRSA 48 ct, Catalog #441244. IDI-MRSA assay is a qualitative in vitro diagnostic test for the direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in healthcare settings. The test performed on the Smart Cycler instrument with a nasal swab specimen from patients at risk for colonization, utilizes polymerase chain reaction (PCR) for the amplification of MRSA DNA and fluorgenic target-specific hybridization probes for the detection of amplified DNA. IDI-MRSA assay is not intended to diagnose MRSA infections nor to guide or monitor treatment for MRSA infections. Concomitant cultures are necessary only to recover organisms for epidemiological typing or for further susceptibility testing.

    FDA Recall
    Terminated ·BD Diagnostics (GeneOhm Sciences, Inc)·Product code NQX·July 21, 2008

    CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct immunofluorescence reagent for enumerating percentages of mature human suppressor/cytotoxic (CD8+) lymphocytes in erythrocyte-lysed whole blood or peripheral blood mononuclear cell suspensions.

    FDA Recall
    Terminated ·BD Biosciences, Systems & Reagents·Product code GKL·December 19, 2014

    BD DifcoTM Neisseria Meningitidis Antisera Group Y 241113, 1mL, in vials, which were labeled in part, 8019456 6250890 N. MEN. GP Y UNLABELED LYOPH, Becton, Dickinson and Company, Sparks, MD 21152. The product is packaged in 100 vial units For use in slide agglutination tests for serotyping Neisseria Meningitidis.

    FDA Recall
    Terminated ·BD Diagnostic Systems Lee Laboratories·Product code GTJ·September 6, 2007

    BD DifcoTM Neisseria Meningitidis Antiserum Group Y 241113, 1mL, in vials, which were labeled in part, 8019456 6250890 N. MEN. GP Y UNLABELED LYOPH, Becton, Dickinson and Company, Sparks, MD 21152. The product is packaged in 100 vial units For use in slide agglutination tests for serotyping Neisseria Meningitidis.

    FDA Recall
    Terminated ·BD Diagnostic Systems Lee Laboratories·Product code GTJ·September 6, 2007

    BD FACS Sample Prep Assistant III; (BD SPA III), Manufactured by BD Biosciences, San Jose, CA. The intended use for the BD FACS Sample Prep Assistant is to prepare human whole blood samples for flow cytometry analysis.

    FDA Recall
    Terminated ·BD Biosciences, Systems & Reagents·Product code GKZ·February 19, 2010

    BD FACSCount Controls Kit, An Automated Differential Cell Counter, Model/Catalog Number: P/N: 340166, Product is manufactured and distributed by BD Biosciences, San Jose, CA The reagents are for in vitro diagnostic use on a BD FACSCount instrument.

    FDA Recall
    Terminated ·BD Biosciences, Systems & Reagents·Product code GKZ·January 29, 2009

    BD Diagnostics, BD GeneOhm MRSA Assay, REF: 441242 (200 Reaction Kit) and 441244 (48 Reaction Kit). For the rapid detection of methicillin resistant MRSA DNA in nasal specimen.

    FDA Recall
    Terminated ·BD Diagnostics (GeneOhm Sciences, Inc)·Product code NQX·November 11, 2008

    BD Bioscience CD45 APC-H7 Analyte Specific Reagent, manufactured by BD Biosciences, San Jose, CA. CD45 recognizes members of the T200 family of human leucocyte antigens with molecular mass of 180 to 220 kilodaltons (kDa).

    FDA Recall
    Terminated ·BD Biosciences, Systems & Reagents·Product code MVU·November 23, 2009

    BD Biosciences, BD FACS Sample Prep Assistant II (SPA II), blood sample preparer for flow cytometry analysis

    FDA Recall
    Terminated ·BD Biosciences, Systems & Reagents·Product code GKZ·February 19, 2010

    BD FACS Sample Prep Assistant (SPA and SPA II) Instrument, Model Number: 334080, Product is manufactured and distributed by BD Biosciences, San Jose, CA The intended use for the BD FACS Sample Prep Assistant (SPA and SPA II) is to prepare human whole blood for flow cytometry.

    FDA Recall
    Terminated ·BD Biosciences, Systems & Reagents·Product code JQW·January 3, 2009

    Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against human epithelial adhesion molecule that has been identified as a 40 -kilodalton (kd) protein in Western Blotting.

    FDA Recall
    Terminated ·BD Biosciences, Systems & Reagents·Product code MVU·April 4, 2014

    BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use.

    FDA Recall
    Terminated ·BD Biosciences, Systems & Reagents·Product code OYE·March 6, 2015

    CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent

    FDA Recall
    Terminated ·BD Biosciences, Systems & Reagents·Product code MVU·March 23, 2015

    Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.

    FDA Recall
    Terminated ·Lumenis Limited 13 Hayetzira St., Yokneam Ind. Park Yokneam Israel·Product code GEX·March 25, 2015