Events

Recall of Device Recall SARKEN STAT! 1 Panel Test KitmAMP

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sarken, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    65841
  • Event Risk Class
    Class 2
  • Event Number
    Z-2052-2013
  • Event Initiated Date
    2013-07-29
  • Event Date Posted
    2013-08-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-07-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120451
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Enzyme immunoassay, amphetamine - Product Code DKZ
  • 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.

Device

Device Recall SARKEN STAT! 1 Panel Test KitmAMP
  • Model / Serial
    Manufacturer's Product Number DMA-114  Lot Number MET2100027  Expiration Date: 08/2014
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the country Virgin Islands
  • Product Description
    SARKEN STAT! 1- Panel Test Kit-mAMP || Product Usage: || Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
  • Manufacturer
    Sarken, Inc.

Manufacturer

Sarken, Inc.
  • Manufacturer Address
    Sarken, Inc., 720 S Smith Rd, STE 101, Tempe AZ 85281-2925
  • Manufacturer Parent Company (2017)
    Sarken Inc
  • Source
    USFDA