BEUDAMED
    FDA Recall Terminated

    SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).

    Recall: Z-2049-2013 · Initiated July 29, 2013

    Recall

    Recall Number
    Z-2049-2013
    Event Number
    65841
    Firm
    Sarken, Inc.
    FEI Number
    3000297792
    Product Code
    DKZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 29, 2013
    Posted
    August 23, 2013
    Terminated
    July 16, 2014
    Address
    720 S Smith Rd, STE 101, Tempe, AZ, 85281-2925

    Description

    SARKEN STAT! Multi-Drug Test Panel 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.

    Action

    Firm notified customers via telephone, followed up with MEDICAL DEVICE RECALL letter dated July 29, 2013 sent 08/02/13, via USPS regular mail to all affected customers. The recall notification letter is accompanied by a return response, acknowledgement and receipt form. The letter notify customers of the voluntary recall, product description (with prodcut images), reason for recall, potential impact, instructions/actions to follow, and contact information.

    Distribution

    Worldwide Distribution - US Nationwide in the country Virgin Islands

    Quantity

    various quantities