BEUDAMED
    FDA Enforcement Class II Terminated

    SARKEN STAT! 1- Panel Test Kit-OPI Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).

    Recall: Z-2053-2013 · Reported September 4, 2013

    Enforcement

    Recall Number
    Z-2053-2013
    Event ID
    65841
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sarken, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 4, 2013
    Initiation Date
    July 29, 2013
    Classification Date
    August 23, 2013
    Termination Date
    July 16, 2014
    Address
    720 S Smith Rd, STE 101, Tempe, AZ, 85281-2925, United States

    Description

    SARKEN STAT! 1- Panel Test Kit-OPI Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).

    Reason

    These products are being recalled because they were distributed without adequate labeling and instructions for use. Inadequate labeling could lead to misuse of the Test Kits and incorrect test results.

    Code Info

    Manufacturer's Product Number DOP-114 Lot Number OPI2100003 Expiration Date: 09/2014

    Distribution

    Worldwide Distribution - US Nationwide in the country Virgin Islands

    Quantity

    various quantities