Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall SARKEN STAT! 1 Panel Test KitOPI

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall SARKEN STAT! 1 Panel Test KitOPIsee related information
Date Initiated by FirmJuly 29, 2013
Date PostedAugust 23, 2013
Recall Status1 Terminated 3 on July 16, 2014
Recall NumberZ-2053-2013
Recall Event ID 65841
Product Classification Enzyme immunoassay, opiates - Product Code DJG
ProductSARKEN 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
FEI Number 3000297792
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
ActionFirm 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 Commercevarious quantities
DistributionWorldwide Distribution - US Nationwide in the country Virgin Islands
Total Product Life CycleTPLC 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.
-
-