Sarken, Inc.: 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.

Agency Publication Date: August 23, 2013

Affected Products

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

Manufacturer's Product Number HMO-W264 Lot Number F2290966 Expiration Date: 02/2014

Lot Numbers:

Number

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

Manufacturer's Product Number DOA-254 Lot Number DOA2050035 DOA2090666 DOA2110059 DOA2120771 Expiration Date: 02/2014 07/2014 08/2014 10/2014

Lot Numbers:

Number

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

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

Lot Numbers:

Number

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

Manufacturer's Product Number DCO-114 Lot Number COC2010004 COC2110076 Expiration Date: 12/2013 09/2014

Lot Numbers:

Number

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

Manufacturer's Product Number DMA-114 Lot Number MET2100027 Expiration Date: 08/2014

Lot Numbers:

Number

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

Manufacturer's Product Number DOP-114 Lot Number OPI2100003 Expiration Date: 09/2014

Lot Numbers:

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 65841

Status: Resolved

Manufacturer: Sarken, Inc.

Manufactured In: United States

Units Affected: 6 products (various quantities; various quantities; various quantities; various quantities; various quantities; various quantities)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

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

Manufacturer's Product Number HMO-W264 Lot Number F2290966 Expiration Date: 02/2014

Lot Numbers:

Number

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

Manufacturer's Product Number DOA-254 Lot Number DOA2050035 DOA2090666 DOA2110059 DOA2120771 Expiration Date: 02/2014 07/2014 08/2014 10/2014

Lot Numbers:

Number

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

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

Lot Numbers:

Number

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

Manufacturer's Product Number DCO-114 Lot Number COC2010004 COC2110076 Expiration Date: 12/2013 09/2014

Lot Numbers:

Number

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

Manufacturer's Product Number DMA-114 Lot Number MET2100027 Expiration Date: 08/2014

Lot Numbers:

Number

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

Manufacturer's Product Number DOP-114 Lot Number OPI2100003 Expiration Date: 09/2014

Lot Numbers:

Number