Devices

Device Recall ZYMUTEST HIA IgGAM

  • Model / Serial
    UDI: 03663537018770 Lot Number: F1700415
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution and to the countries of : Austria and France.
  • Product Description
    ZYMUTEST HIA IgGAM. || Model Number: RK040D. || Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 96 Tests.
  • Manufacturer
    Hyphen BioMed
  • 1 Event

Manufacturer

Hyphen BioMed
  • Manufacturer Address
    Hyphen BioMed, 155 rue d Eragny, Neuville Sur Oise France
  • Manufacturer Parent Company (2017)
    Hyphen Biomed
  • Source
    USFDA

One device with a similar name

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Device Recall ZYMUTEST HIA IgGAM ELISA
  • Model / Serial
    Lot numbers: F1600568P1, F1600568P2, F1700415P1, F1700415P2, F1701369P1, F1701369P2
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    OH, MD, NC, NY, NH, Canada, Sweden
  • Product Description
    ZYMUTEST HIA IgGAM; REF Number: RK040D; UDI: 03663537018770 a qualitative screening assay intended for the global detection of heparin- dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma, by clinical laboratories.
  • Manufacturer
    Hyphen BioMed