BEUDAMED
    124 results · 12ms · Sources: EU EUDAMED, US FDA

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    BD Vacutainer EDTA Tan Top Tube; Catalog Number: 367855 (UDI: 50382903678551)

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code JKA·March 22, 2018

    BD Vacutainer Lithium Heparin Green Top Tube; Catalog Numbers: 1. 366664 (UDI: 50382903666640); 2. 367884 (UDI: 50382903678841); 3. 367886 (UDI: 50382903678865); 4. 368040 (UDI: 50382903680400); 5. 366667 (UDI: 50382903666671); 6. 367880 (UDI: 50382903678803)

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code JKA·March 22, 2018

    BD Vacutainer EDTA Pink Top Tube; Catalog Numbers: 1. 367842 (UDI: 50382903678421); 2. 367899 (UDI: 50382903678995); 3. 368049 (UDI: 50382903680493); 4. 368589 (UDI: 50382903685894)

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code JKA·March 22, 2018

    MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection and differentiation of HSV-1 and HSV-2 present in cerebrospinal fluid (CSF), or cutaneous and mucocutaneous lesion swabs from patients with signs and symptoms of HSV-1 or HSV-2 infection of the central nervous system (CNS) or cutaneous and mucocutaneous lesions.

    FDA Recall
    Terminated ·DiaSorin Molecular LLC·Product code OQO·May 12, 2020

    BD Vacutainer EDTA Lavender Top Tubes: Catalog Numbers: 1. 366401 (UDI: 50382903664011); 2. 366450 (UDI: 50382903664509); 3. 366643 (UDI: 50382903666435); 4. 367835 (UDI: 50382903678353); 5. 367841 (UDI: 50382903678414); 6. 367844 (UDI: 50382903678445); 7. 367856 (UDI: 50382903678568); 8. 367861 (UDI: 50382903678612); 9. 367862 (UDI: 50382903678629); 10. 367863 (UDI: 50382903678636); 11. 368021 (UDI: 50382903680219); 12. 368047 (UDI: 50382903680479); 13. 368054 (UDI: 50382903680547); 14. 368661 (UDI: 50382903686617); 15. 364300 (UDI: pre-UDI)

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code JKA·March 22, 2018

    MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection and differentiation of HSV-1 and HSV-2 present in cerebrospinal fluid (CSF), or cutaneous and mucocutaneous lesion swabs from patients with signs and symptoms of HSV-1 or HSV-2 infection of the central nervous system (CNS) or cutaneous and mucocutaneous lesions.

    FDA Enforcement
    Class II ·Terminated·DiaSorin Molecular LLC·July 22, 2020

    HSV 2 Primers, Catalog #18081020. Analyte Specific Reagent. The HSV-2 primer pair is specific for HSV-2 (Herpes Simplex Virus 2). For use in Clinical laboratories when developing their own diagnostic tests.

    FDA Recall
    Terminated ·Life Technologies Corporation·Product code NYQ·May 13, 2013

    Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Product Code 363420 The Infusomat Space Pump IV Set, 2 Caresites, ASV with 0.2 Micron Air Eliminating Filter and Anti-Syphon Valve (ASV) is a latex-free product intended to be used with the Infusomat Space Pump, to deliver intravenous solutions. The 0.2 Micron filter is a clear acrylic in-line filter designed to eliminate air within the IV infusion set. While it is not listed in the labeling, it is known that the filter is used for removal of particulate matter for some medications and at risk patient populations.

    FDA Enforcement
    Class II ·Terminated·B. Braun Medical, Inc.·July 4, 2018

    HSV 2 Primers, Catalog #18081020. Analyte Specific Reagent. The HSV-2 primer pair is specific for HSV-2 (Herpes Simplex Virus 2). For use in Clinical laboratories when developing their own diagnostic tests.

    FDA Enforcement
    Class II ·Terminated·Life Technologies Corporation·September 4, 2013

    BD Vacutainer¿ EDTA Tan Top Tube; Catalog Number: 367855 (UDI: 50382903678551)

    FDA Enforcement
    Class I ·Terminated·Becton Dickinson & Company·March 28, 2018

    HSV-2 IgG ELISA kit ; HSV-2 IgM ELISA kit; BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.

    FDA Recall
    Terminated ·BioCheck Inc·Product code LGC·December 22, 2010

    HSV-1 IgG ELISA kit ; HSV-1 IgM ELISA kit; BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.

    FDA Recall
    Terminated ·BioCheck Inc·Product code LGC·December 22, 2010

    BD Vacutainer¿ EDTA Pink Top Tube; Catalog Numbers: 1. 367842 (UDI: 50382903678421); 2. 367899 (UDI: 50382903678995); 3. 368049 (UDI: 50382903680493); 4. 368589 (UDI: 50382903685894)

    FDA Enforcement
    Class I ·Terminated·Becton Dickinson & Company·March 28, 2018

    BD Vacutainer¿ Lithium Heparin Green Top Tube; Catalog Numbers: 1. 366664 (UDI: 50382903666640); 2. 367884 (UDI: 50382903678841); 3. 367886 (UDI: 50382903678865); 4. 368040 (UDI: 50382903680400); 5. 366667 (UDI: 50382903666671); 6. 367880 (UDI: 50382903678803)

    FDA Enforcement
    Class I ·Terminated·Becton Dickinson & Company·March 28, 2018

    HerpeSelect 1 and 2 Immunoblot IgG Kit, IB0900G Intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-1 and HSV-2 in human sera.

    FDA Recall
    Terminated ·Focus Diagnostics Inc·Product code LGC·July 6, 2007

    Product is labeled in part: "***is immunosimplicity***HSV 1&2 IgM***Enzyme Immunoassay Test Kit***For the Detection of HSV 1&2 IgM antibodies***Catalog No: 720-350***Exp. Date:***Contains Sufficient for 96 Tests***C - Corrosive Harmful***Lot No: ***For In Vitro Diagnostic Use***Caution, consult accompanying documents.***Manufacturer***Diamedix***A Subsidiary of IVAX Diagnostics, Inc. MIAMI, FL 33127 USA-1-800-327-4565***Biohazard***" The Is-HSV 1&2 IgM test kits are packaged in cardboard boxes with individual components secured within a foam insert. The Diamedix Is-HSV 1&2 IgM Test Kit is intended for the qualitative detection of IgM antibodies to herpes simplex virus (HSV) type 1 and/or type 2 in human serum by indirect enzyme immunoassay. This test can aid in the diagnosis of a primary or reactived infection with HSV. The performance of this assay has not bee established for use in neonates, infants, or on cord blood, and immunocompromised patients.

    FDA Recall
    Terminated ·Diamedix Corporation·Product code LGC·January 16, 2012

    BD Vacutainer¿ EDTA Lavender Top Tubes: Catalog Numbers: 1. 366401 (UDI: 50382903664011); 2. 366450 (UDI: 50382903664509); 3. 366643 (UDI: 50382903666435); 4. 367835 (UDI: 50382903678353); 5. 367841 (UDI: 50382903678414); 6. 367844 (UDI: 50382903678445); 7. 367856 (UDI: 50382903678568); 8. 367861 (UDI: 50382903678612); 9. 367862 (UDI: 50382903678629); 10. 367863 (UDI: 50382903678636); 11. 368021 (UDI: 50382903680219); 12. 368047 (UDI: 50382903680479); 13. 368054 (UDI: 50382903680547); 14. 368661 (UDI: 50382903686617); 15. 364300 (UDI: pre-UDI)

    FDA Enforcement
    Class I ·Terminated·Becton Dickinson & Company·March 28, 2018

    EPIQ 5 Ultrasound System, EPIQ 5 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: EPIQ 5G, EPIQ 5C, EPIQ 5W. Catalog Number: 795204 / 795205 and Part Number: 989605408541 Diagnostic Ultrasound Imaging.

    FDA Enforcement
    Class II ·Terminated·Philips Ultrasound, Inc.·December 24, 2014

    ARIES HSV 1&2 Assay, Catalog/REF# 50-10017

    FDA Recall
    Terminated ·Luminex Corporation·Product code OOI·November 17, 2021

    ARIES HSV 1&2 Assay, Catalog/REF# 50-10017

    FDA Enforcement
    Class II ·Terminated·Luminex Corporation·February 9, 2022