BEUDAMED
    FDA Enforcement Class II 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 · Reported May 6, 2020

    Enforcement

    Recall Number
    Z-1800-2020
    Event ID
    85074
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Bio-Rad Labs
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 6, 2020
    Initiation Date
    April 3, 2019
    Classification Date
    April 24, 2020
    Address
    5500 E 2nd St, N/A, Benicia, CA, 94510-1020, United States

    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.

    Code Info

    Catalog Number 425-2260; Lot Number 18200A: UDI 00847817018336.

    Distribution

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

    Quantity

    376 units