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U.S. Department of Health and Human Services

Class 2 Device Recall Model BP7507 OPTI LION EPlus Cassette

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  Class 2 Device Recall Model BP7507 OPTI LION EPlus Cassette see related information
Date Initiated by Firm August 09, 2013
Date Posted October 18, 2013
Recall Status1 Terminated 3 on December 12, 2013
Recall Number Z-0029-2014
Recall Event ID 66105
510(K)Number K052027  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical

Cassettes are consumable used in the OPTI LION Electrolyte Analyzer intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, serum, and plasma.
Code Information Lots 252810, 315815, 319810, 319815, 321817, 367812, 370812
Recalling Firm/
Manufacturer		 OPTI Medical Systems, Inc
235 Hembree Park Dr
Roswell GA 30076-5738
For Additional Information Contact Len Owens
770-510-4444
Manufacturer Reason
for Recall		 OPTI LION E-Plus Cassettes were labeled with an incorrect barcode. The incorrect barcode could perfect the performance of one or more parameters as the product ages. Also a Customer complaint from a distributor reported that a customer was getting QC failures.
FDA Determined
Cause 2		 Error in labeling
Action The firm, OPTIMedical, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated August 9, 2013 via email and fax to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use of the product; return any unused product to OPTI Medical System; distributors outside the U.S. may destroy unused product and certify the instructions on the enclosed Recall Response Card; contact your distributor or OPTI Medical System Technical Support at 1-800-490-6784 or technicalsupport@optimedical.com to obtain authorization number and shipping instructions; and complete and return the Recall Response Card to technical support via fax to 1-770-510-4447; mail to: OPTI Medical Technical Support, OPTI Medical Systems, Inc., 235 Hembree Park Drive, Roswell, GA 30076 or email: technicalsupport@optimedical.com Please contact OPTI Medical Systems, Technical Support department at 1-800-490-6784 if you have questions related to this notice.
Quantity in Commerce 361 boxes of 25 cassettes each
Distribution Worldwide distribution: US (nationwide) including states of: CA, MA, MN, and VA; and countries of: China, Guatemala, India, Iraq, South Korea, and Untied Arab Emirates.
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.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = OSMETECH, INC.
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