BEUDAMED
    FDA Recall Completed

    Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test; Material Number 425-2260; Lot number 18200A - Product Usage: The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings.

    Recall: Z-1800-2020 · Initiated April 3, 2019

    Recall

    Recall Number
    Z-1800-2020
    Event Number
    85074
    Firm
    Bio-Rad Labs
    FEI Number
    1000135116
    Product Code
    MVM
    Status
    Completed
    Root Cause
    Under Investigation by firm
    Initiated
    April 3, 2019
    Address
    5500 E 2nd St, Benicia, CA, 94510-1020

    Description

    Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test; Material Number 425-2260; Lot number 18200A - Product Usage: The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings.

    Reason

    An elevated lot-to-lot bias was observed for Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA when compared to a previous lot of product. The observed elevated bias between these two lots is largely due to samples with higher levels of antibodies. With the cut-off for the assay being 15 U/mL, the clinical classifications for most samples would remain unchanged.

    Action

    On April 3, 2019, a Field Action Letter with response form was sent to U.S. Customers via Fed Ex courier while subsidiaries were notified via email. Customers were instructed to immediately discontinue further use of, and dispose of, any unused product according to local waste management procedures. Customers were requested to complete the attached customer response form as an acknowledgement with information including: account name, customer account number, contact name and title, address, and telephone number. Customers were instructed to check off the statement acknowledging awareness of the field action and that they had proceeded according to instructions issued by Bio-Rad. Completed forms were to be returned to [email protected]. Customers were instructed to contact their local Bio-Rad Technical Support with any questions regarding the Field Action Notification.

    Distribution

    US Nationwide distribution including the states of AZ, NY, LA, FL, CA, TX, IA, MS, UT, and IL.

    Quantity

    376 units