BEUDAMED
    FDA Enforcement Class III Terminated

    Sterling Diagnostics, Inc., SGPT Colorimetric for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.

    Recall: Z-0935-2017 · Reported January 4, 2017

    Enforcement

    Recall Number
    Z-0935-2017
    Event ID
    75591
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sterling Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    January 4, 2017
    Initiation Date
    July 20, 2016
    Classification Date
    December 29, 2016
    Termination Date
    March 22, 2017
    Address
    36645 Metro Ct, N/A, Sterling Heights, MI, 48312-1009, United States

    Description

    Sterling Diagnostics, Inc., SGPT Colorimetric for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.

    Reason

    Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.

    Code Info

    SGPT Colorimetric, CAT No. 2260-0 , Lot No. 26051, Expriry: 4/18, Manufactured: 04/27/15

    Distribution

    Domestic: MI Foreign: Phillipines VA/DOD: None

    Quantity

    51