Class 2 Device Recall BP7561 OPTI CCATS BLac Cassette

• Date Initiated by Firm: July 03, 2012
• Date Posted: September 21, 2012
• Recall Status: Terminated on April 11, 2013
• Recall Number: Z-2440-2012
• Recall Event ID: 62606
• 510(K)Number: K093280
• Product Classification: Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
• Product: BP7561 OPTI CCA-TS B-Lac Cassette (25 per box) Cassettes are consumables used in the OPTI CCA-TS Analyzer intended to be used for in vitro measurements of pH, PCOX2 PO2, lactate (lactic acid), total hemoglobin (tHb), and oxygen saturation (SO2), in heparinized whole blood samples (either arterial or venous) on the OPTI CCA-TS system, in either a clinical setting or point of care locations. Cassettes contain one-time use sensors that are used with the OPTI CCA-TS analyzer to perform in-vitro measurements of blood gases and metabolites. OPTI CCA-TS B-Lac Cassettes are supplied in boxes of 25 and may only used with the OPTI CCA-TS Analyzer.
• Code Information: Lot numbers: 110650, 114650, 114651, 114652, 114653, 116650, 116652, 117650, 118651, 121650, 121651, 122652, 122652, 122653, 122654, 122655, 122656, 122657, 123654, 123655, 124650, 133650, 134651, 136650, 146650, 149650, 202650, 208650, 208651, 209560, 209651, 211650, 212651, 213650, 214650, 215650, 215651, 221650, 222650 and 224650.
• FEI Number: 3004102403
• 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. 81658
• Manufacturer Reason for Recall: The values reported for PCO2 by BP7561 B-Lac cassettes are biased at high concentrations when used at altitudes above 2800 feet (853 meters).
• FDA Determined Cause: Process design
• Action: OPTI Medical sent a Urgent Field Correction Notice dated July 3, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to apply correlation factors to correct the PCO2 measurement reported by the device. They were instructed to determine the elevation (altitude above sea level) for their location and to use the tables provided in the recall notification to determine the correct correlation factor. A website was provided if the consignee did not know their elevation. Steps were provided to enter the correlation factor into their OPTI CCA TS analyzer. Please contact OPTI Medical Technical Support at 1-770-510-4444 or 1-800-490-6784.
• Quantity in Commerce: 895 boxes (25 cassettes per box)
• Distribution: Worldwide Distribution -- US (nationwide) including the states of AZ, ID, TX and UT., and the countries of Argentina, Bolivia, China, Ecuador, France, Germany Greece, India, Indonesia, Iran, Ireland, Japan, Kuwait, Lithuania, Luxembourg, Malaysia, Mexico, Morocco, Nigeria, Poland, Romania, Russia, Saudi Arabia, Singapore, South Africa, Sudan Switzerland, Turkey, United kingdom, Venezuela, and Viet Nam.
• 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 = CHL