Sarken, Inc.: Medical Device Recall in 2013 - (Recall #: Z-2050-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 29, 2013

Date Posted: September 4, 2013

Recall Number: Z-2050-2013

Event ID: 65841

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.

Status: Terminated

Product Quantity: various quantities

Code Information:

Manufacturer's Product Number DTH-114 Lot Number THC1120052 THC2120005 THC211100044 THC2100044 THC2120006 Expiration Date: 12/2013 10/2014 09/2014 09/2014 11/2014

Distribution Pattern:

Worldwide Distribution - US Nationwide in the country Virgin Islands

Voluntary or Mandated:

Voluntary: Firm initiated