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Terminated

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

FDA Recall Z-2050-2013 · Posted 2013-08-23

Recalling FirmSarken, Inc.
Recall StatusTerminated
Product CodeLDJ
Date Initiated2013-07-29
Date Terminated2014-07-16
Product Quantityvarious 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.

Firm 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.

Root Cause

Other

Distribution Pattern

Worldwide Distribution - US Nationwide in the country Virgin Islands

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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