SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
FDA Recall Z-2049-2013 · Posted 2013-08-23
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Recalling FirmSarken, Inc.
Recall StatusTerminated
Product CodeDKZ
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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