PlainRecalls
FDA Devices Moderate Class II Terminated

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 m

Reported: October 3, 2012 Initiated: July 3, 2012 #Z-2440-2012

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.

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).

Details

Recalling Firm
OPTI Medical Systems, Inc
Units Affected
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.
Location
Roswell, GA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by OPTI Medical Systems, Inc. Units affected: 895 boxes (25 cassettes per box).
Why was this product recalled? ▼
The values reported for PCO2 by BP7561 B-Lac cassettes are biased at high concentrations when used at altitudes above 2800 feet (853 meters).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 3, 2012. Severity: Moderate. Recall number: Z-2440-2012.

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