BEUDAMED
    FDA Enforcement Class II Terminated

    DRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI Salicylate Serum Tox Assay is intended for the quantitative determination of salicylate in human serum or plasma.

    Recall: Z-2884-2016 · Reported October 5, 2016

    Enforcement

    Recall Number
    Z-2884-2016
    Event ID
    74861
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Microgenics Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 5, 2016
    Initiation Date
    July 25, 2016
    Classification Date
    September 23, 2016
    Termination Date
    November 21, 2016
    Address
    46500 Kato Rd, N/A, Fremont, CA, 94538-7310, United States

    Description

    DRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI Salicylate Serum Tox Assay is intended for the quantitative determination of salicylate in human serum or plasma.

    Reason

    Some lots of DRI Salicylate Serum Tox Assay negative patient samples are recovering higher than the product sensitivity claim of 4.4 mg/dL.

    Code Info

    Lot Number Expiration Date 60704602 DEC 2016; 72035410 JUL 2017; 72208738 FEB 2018; 72409454 OCT 2018.

    Distribution

    Worldwide Distribution: US (nationwide) to states of: AZ, CA, MO, TX, and PR and countries of: Canada, Germany, Hong Kong, Italy, Malaysia, and Taiwan.

    Quantity

    1708 kits