OPTI Medical Systems, Inc: Medical Device Recall in 2012 - (Recall #: Z-2440-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 3, 2012

Date Posted: October 3, 2012

Recall Number: Z-2440-2012

Event ID: 62606

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).

Status: Terminated

Product Quantity: 895 boxes (25 cassettes per box)

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.

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.

Voluntary or Mandated:

Voluntary: Firm initiated