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U.S. Department of Health and Human Services

Enforcement Report - Week of September 4, 2013

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Product Detail

Product Description SARKEN STAT! 1- Panel Test Kit-COC Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
Recall Number Z-2051-2013
Classification Class II
Code Info Manufacturer's Product Number DCO-114 Lot Number COC2010004 COC2110076 Expiration Date: 12/2013 09/2014
Product Distributed Qty various quantities
Reason For Recall 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.

Event Detail

Event Id 65841
Product Type Devices
Status Ongoing
Recalling Firm Sarken, Inc.
City Tempe
State AZ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-29
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - US Nationwide in the country Virgin Islands