BEUDAMED
    FDA Enforcement Class II Terminated

    Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007

    Recall: Z-1774-2022 · Reported September 28, 2022

    Enforcement

    Recall Number
    Z-1774-2022
    Event ID
    90820
    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
    September 28, 2022
    Initiation Date
    August 17, 2022
    Classification Date
    September 20, 2022
    Termination Date
    June 12, 2024
    Address
    124 Bernard E Saint Jean Drive, N/A, East Falmouth, MA, 02536-4445, United States

    Description

    Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007

    Reason

    Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to printed information for reconstitution and pretreatment volumes

    Code Info

    UDI-DI: 00862696000227 Lot # FK22008 and Package Control # 113041 Exp. Date: 2023-11-21

    Distribution

    Worldwide distribution - US Nationwide distribution in the state of CA and the countries of Austria, France, Germany, India, Ireland, Italy, Spain, UK.

    Quantity

    243 kits