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 OPTI LION EPlus

  • 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 OPTI LION EPlussee related information
Date Initiated by FirmJuly 18, 2007
Date PostedNovember 09, 2007
Recall Status1 Terminated 3 on December 13, 2007
Recall NumberZ-0119-2008
Recall Event ID 44880
510(K)NumberK052027 
Product Classification Sodium/Chloride Test System - Product Code JGS
ProductOPTI LION E-Plus Cassettes, Model BP7507, (25 per box), In Vitro Diagnostic, OPTI Medical Systems, Inc., Roswell, Georgia 30076
Code Information Lot Numbers: 701800, 706800, 710801, 711800, 711801, 712800, 713800, 714800, 714801, 714802, and 718800
FEI Number 3004102403
Recalling Firm/
Manufacturer		 Opti Medical Systems Inc
235 Hembree Park Dr Ste 200
Roswell GA 30076-5700
For Additional Information ContactLen Owens
770-510-4444 Ext. 4466
Manufacturer Reason
for Recall		Incorrect results/stability failure; Actual device stability studies show sodium and chloride sensors age differently than anticipated when stored at the high end of labeled storage, therefore subsequent measurements give results outside the allowed error allowance before the 6 month expiration date shown on the device.
FDA Determined
Cause 2		Device Design
ActionAn Urgent Medical Device Recall Letter dated 16 July 2007, was issued via E mail and Fax on/or about 7/18/2007 directing consignees to remove unused cassettes from inventory and destroy them. Replacement cassettes will be shipped upon receipt of information regarding destruction by calling customer service at 800-490-6784. Sub-recall by distributors was requested.
Quantity in Commerce289 boxes of 25 cassettes
DistributionWorldwide Distribution-USA, Australia, Chile, China, Egypt, France, Great Britain, Guatemala, Indonesia, Italy, Korea, Lebanon, Mauritania, Morocco, Nepal, Russia, South Africa, Sweden, Tanzania, Thailand, and Venezuela.
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.
510(K) Database510(K)s with Product Code = JGS
-
-