BEUDAMED
    FDA Recall 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 · Initiated December 19, 2018

    Recall

    Recall Number
    Z-1329-2019
    Event Number
    82551
    Firm
    Associates of Cape Cod, Inc. 124 Bernard E Saint Jean East
    FEI Number
    1219145
    Product Code
    NQZ
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    December 19, 2018
    Terminated
    May 12, 2020
    Address
    Falmouth, MA, 02536-4445

    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.

    Action

    Important Message to Customers Concerning Fungitell Kit Configuration letters dated 12/19/18 were sent to customers.

    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