BEUDAMED
    FDA Enforcement Class II Terminated

    Fungitell Kit, Catalog FT001 - Product Usage: The Fungitell assay is a potease zymogen-based colorimetric assay for the qualitative detection of (1-3)Beta-D Glucan in the serum of patients with symptoms of,or medical conditions predisposing the patient to, invasive fungal infection. The serum concentration of (1-3)Beta-D Glucan, a major cell wall component of various medically important fungi, can be used as an aid in teh diagnosis of deep-seated mycoses and funemias. A positve result does not indicate which genus of fungi may be causing the infection. (1-3)Beta-D Glucan titers should be used in conjunction with other diagnostic procedures, such as microbiological culture, histological examination of biopsy samples and radiological examination.

    Recall: Z-1329-2019 · Reported May 22, 2019

    Enforcement

    Recall Number
    Z-1329-2019
    Event ID
    82551
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Associates of Cape Cod, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 22, 2019
    Initiation Date
    December 19, 2018
    Classification Date
    May 14, 2019
    Termination Date
    May 12, 2020
    Address
    124 Bernard E Saint Jean, East Falmouth, MA, 02536-4445, United States

    Description

    Fungitell Kit, Catalog FT001 - Product Usage: The Fungitell assay is a potease zymogen-based colorimetric assay for the qualitative detection of (1-3)Beta-D Glucan in the serum of patients with symptoms of,or medical conditions predisposing the patient to, invasive fungal infection. The serum concentration of (1-3)Beta-D Glucan, a major cell wall component of various medically important fungi, can be used as an aid in teh diagnosis of deep-seated mycoses and funemias. A positve result does not indicate which genus of fungi may be causing the infection. (1-3)Beta-D Glucan titers should be used in conjunction with other diagnostic procedures, such as microbiological culture, histological examination of biopsy samples and radiological examination.

    Reason

    The kits may contain the incorrect number of components or the kits may be missing components.

    Code Info

    Lot FK18005

    Distribution

    Worldwide distribution - US nationwide in the states of CA, FL, MD, UT, VA and countries of Singapore, South Africa, United Kingdo.m

    Quantity

    795