Recall Z-2440-2012 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
OPTI Medical Systems, Inc
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. Casset
| Date | Sep 21, 2012 (initiated Jul 3, 2012) |
| Status | Terminated |
| Reason | The values reported for PCO2 by BP7561 B-Lac cassettes are biased at high concentrations when used at altitudes above 2800 feet (853 meters). |
| Root 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 en |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093280 | OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561 Opti Medical Systems, Inc., Jan 7, 2011 |