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

FDA device recall Z-2051-2013 · posted 2013-08-23 · Terminated

Recall details

Recalling firm

Sarken, Inc.

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

DIO

Quantity affected

various quantities

Distribution

Worldwide Distribution - US Nationwide in the country Virgin Islands

Date initiated

2013-07-29

Date posted

2013-08-23

Date terminated

2014-07-16

Location

Tempe, AZ