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U.S. Department of Health and Human Services

Enforcement Report - Week of October 3, 2012

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Product Detail

Product Description 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.
Recall Number Z-2440-2012
Classification Class II
Code Info 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.
Product Distributed Qty 895 boxes (25 cassettes per box)
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).

Event Detail

Event Id 62606
Product Type Devices
Status Ongoing
Recalling Firm OPTI Medical Systems, Inc
City Roswell
State GA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-03
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern 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.