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U.S. Department of Health and Human Services

Class 2 Device Recall OPTI LION EPlus

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  Class 2 Device Recall OPTI LION EPlus see related information
Date Initiated by Firm March 15, 2011
Date Posted June 14, 2011
Recall Status1 Terminated 3 on August 08, 2011
Recall Number Z-2558-2011
Recall Event ID 58272
510(K)Number K052027  
Product Classification Electrode, ion-specific, chloride - Product Code CGZ
Product OPTI LION E-Plus Cassette, Model BP7507, Opti Medical (25 Cassettes with Samples Probes per box).

Cassettes are consumables 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. . Cassettes contain one-time use sensors that are used with the OPTI-LION analyzer to perform in-vitro measurements of electrolytes. OPTI LION E-Plus Cassettes are supplied in boxes of 25 and may only be used with the OPTI LION Electrolyte Analyzer.
Code Information Lot numbers 038811 and 102812
Recalling Firm/
Manufacturer		 OPTI Medical Systems, Inc
235 Hembree Park Dr
Roswell GA 30076-5738
For Additional Information Contact Len Owens
770-510-4444 Ext. 573
Manufacturer Reason
for Recall		 The values reported by the chloride sensors may report erroneous values below specification on aqueous controls and potentially with patient samples of whole blood and serum/plasma.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action OPTIMedical Systems sent an "URGENT: MEDICAL DEVICE RECALL" letter dated March 15, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers were notified by letter via e-mail and fax. Customers were instructed to discontinue use of the product and to return any unused product to OPTI Medical Systems, Inc. Customers outside the U.S. were instructed to destroy unused product and certify the destruction on the enclosed Recall Response Card. The Response Card was to be completed and returned to OPTI Medical Customer Service via fax. OPTI Medical Systems will replace the cassettes they have with product from another lot. Customers were instructed to contact the Technical Support Department at 1-800-490-6784 for questions relating to this notice.
Quantity in Commerce 86 boxes (25 units (per box)
Distribution Worldwide Distribution-- USA (nationwide) including states of CA and VA, and countries of India, Lebanon, Philippines, Sweden, Venezuela and Vietnam.
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 = CGZ and Original Applicant = OSMETECH, INC.
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