BEUDAMED
    FDA Recall Terminated

    Enzymatic Cholesterol (Trinder/COD-CEH) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.

    Recall: Z-0929-2017 · Initiated July 20, 2016

    Recall

    Recall Number
    Z-0929-2017
    Event Number
    75591
    Firm
    Sterling Diagnostics, Inc.
    FEI Number
    1831796
    Product Code
    CHH
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    July 20, 2016
    Posted
    December 29, 2016
    Terminated
    March 22, 2017
    Address
    36645 Metro Ct, Sterling Heights, MI, 48312-1009

    Description

    Enzymatic Cholesterol (Trinder/COD-CEH) 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.

    Action

    Sterling Diagnostics, Inc. initiated their voluntary recall on 07/20/2016 by calling customers by phone to determine what kits remianed at customers' and compare withthe firm's sales records. Sterling Diagnostics followed up by sending a letter to each customer, and instructed them to take note of the corrected expiration dates for the dignostic kits, apply the revised dates to the kits in their possession, and return a customer acknowledgement to the Office Manager Luz Santa Maria at Sterling Diagnostics, Inc. at 36645 Metro Court, Sterling Heights, MI 48312. Customers with questions can call 586-979-2141.

    Distribution

    Domestic: MI Foreign: Phillipines VA/DOD: None

    Quantity

    97