FDAClass IISeptember 4, 2013

SARKEN STAT! Multi-Drug Test Panel Product Usage recall: Labeling Error

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

Why was SARKEN STAT! Multi-Drug Test Panel Product Usage recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
Recalling firm
Sarken, Inc.
Quantity
various quantities
Distribution
Worldwide Distribution - US Nationwide in the country Virgin Islands
Recall date
September 4, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls