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.
FDA Recall Z-2440-2012 · Posted 2012-09-21
Recalling FirmOPTI Medical Systems, Inc
Recall StatusTerminated
Product CodeCHL
Date Initiated2012-07-03
Date Terminated2013-04-11
Product Quantity895 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).
Firm 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.
Root Cause
Process design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.