BEUDAMED
    FDA Recall Open, Classified

    FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer

    Recall: Z-0022-2025 · Initiated August 26, 2024

    Recall

    Recall Number
    Z-0022-2025
    Event Number
    95326
    Firm
    Qualigen Inc
    FEI Number
    3003355251
    Product Code
    JLW
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 26, 2024
    Posted
    October 8, 2024
    Address
    2042 Corte Del Nogal, Ste B, Carlsbad, CA, 92011-1438

    Description

    FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer

    Reason

    Thyroid Stimulating Hormone (TSH) calibrator card has an incorrect barcode linked to incorrect information, that may allow successful system calibration, but the TSH results obtained could be higher than expected.

    Action

    On 8/26/24, correction notices were emailed to customers who were asked to do the following: 1) Dispose of affected TSH calibration cards. 2) Use TSH Calibration Card Lot Number 2405017-1R sent with correction notices. 3) Run TSH Quality Control samples. 4) Review and retest any affected TSH results that may have been higher than expected. 5) Notify all relevant parties within your organization or any organization that received the affected devices. 6) Complete and return response forms via email to [email protected] If you have any questions regarding this matter, contact System Support Specialists at [email protected] or (877) 709-2169, option 2.

    Distribution

    US: TX, MS, NY, OH, MT, WA, PA, MN, SC, GA, NC, NV, WY, AK, SD, KS, NE, VT, AL, MA, OK, UT, WI, IA, WV. OUS: Germany, Switzerland

    Quantity

    60