Home / Recalls / Sarken, Inc. / Z-2051-2013

Z-2051-2013 Class II Terminated

Recalled by Sarken, Inc. — Tempe, AZ

Recall Details

Product Type
Devices
Report Date
September 4, 2013
Initiation Date
July 29, 2013
Termination Date
July 16, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
various quantities

Product Description

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

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.

Distribution Pattern

Worldwide Distribution - US Nationwide in the country Virgin Islands

Code Information

Manufacturer's Product Number DCO-114 Lot Number COC2010004 COC2110076 Expiration Date: 12/2013 09/2014

Other recalls by Sarken, Inc.

  • Z-2048-2013 Class II — SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC US (July 29, 2013)
  • Z-2049-2013 Class II — SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC US (July 29, 2013)
  • Z-2052-2013 Class II — SARKEN STAT! 1- Panel Test Kit-mAMP Product Usage: Labeled as FOR FORENSIC (July 29, 2013)
  • Z-2053-2013 Class II — SARKEN STAT! 1- Panel Test Kit-OPI Product Usage: Labeled as FOR FORENSIC U (July 29, 2013)
  • Z-2050-2013 Class II — SARKEN STAT! 1- Panel Test Kit-THC Product Usage- Labeled as FOR FORENSIC US (July 29, 2013)