BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1774-2022 · Initiated August 17, 2022

    Recall

    Recall Number
    Z-1774-2022
    Event Number
    90820
    Firm
    Associates of Cape Cod, Inc.
    FEI Number
    1219145
    Product Code
    NQZ
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    August 17, 2022
    Terminated
    June 12, 2024
    Address
    124 Bernard E Saint Jean Drive East, Falmouth, MA, 02536-4445

    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

    Action

    Associates of Cape Cod, Inc., issued Urgent Device Correction letter via Email to each distributor or customer on 8/17/22 US and outside the US on 8/18/22. Letter states reason for recall, health risk and action to take: Actions required from you: 1. Immediately discontinue the use of the Fungitell STAT Lot # FK22008 and Package Control # 113041. 2. Please complete the attached Acknowledgement of Notification form. a. Include the total number of unused FK22008 kits still in your inventory on the form. b. Coordinate the return of all unused FK22008 kits following the instructions on the form The completed form should be forwarded to [email protected] 3. Please let us know if an adverse event (other than delayed testing) was associated with the recalled product. If you have any questions or concerns, please contact m: Josee Roy, Ph.D., Director, Product Development & Person Responsible for Medical Device Regulatory Compliance (508) 685-8249, [email protected].

    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