Z-2049-2013Class II

SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or...

Name: Z-2049-2013 SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or...
Creator: Sarken, Inc.
Published: 2013-07-29
License: https://open.fda.gov/license/

Sarken, Inc. / initiated 2013-07-29 / Terminated / root cause: labeling and UDI

FDA source

Sarken, Inc. began a recall of SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing) on 2013-07-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2049-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-29
Posted: 2013-08-23
Terminated: 2014-07-16
Recalling firm: Sarken, Inc.
Product: SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
Product code: DKZ Enzyme Immunoassay, Amphetamine
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.
Root cause tag: labeling and UDI
FDA root cause: Other
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.
Quantity in commerce: various quantities
Distribution: Worldwide Distribution - US Nationwide in the country Virgin Islands
Product codes and lots: Manufacturer's Product Number DOA-254 Lot Number DOA2050035 DOA2090666 DOA2110059 DOA2120771 Expiration Date: 02/2014 07/2014 08/2014 10/2014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2049-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2048-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-23
Z-2049-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-23
Z-2050-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-23
Z-2051-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-23
Z-2052-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-23
Z-2053-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-23

Product code DKZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)