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U.S. Department of Health and Human Services

Class 2 Device Recall SARKEN STAT! 1 Panel Test KitOPI

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  Class 2 Device Recall SARKEN STAT! 1 Panel Test KitOPI see related information
Date Initiated by Firm July 29, 2013
Date Posted August 23, 2013
Recall Status1 Terminated 3 on July 16, 2014
Recall Number Z-2053-2013
Recall Event ID 65841
Product Classification Enzyme immunoassay, opiates - Product Code DJG
Product SARKEN STAT! 1- Panel Test Kit-OPI

Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
Code Information Manufacturer's Product Number DOP-114  Lot Number OPI2100003  Expiration Date: 09/2014
Recalling Firm/
Manufacturer		 Sarken, Inc.
720 S Smith Rd
STE 101
Tempe AZ 85281-2925
For Additional Information Contact
480-894-1255
Manufacturer 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.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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