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Recall Observatory FDA recall evidence

Device product

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.

Z-2440-2012

July 03, 2012

Class II

Product summary

Firm
OPTI Medical Systems, Inc
Event
Event 62606
Status
Terminated
Classification
Class II
Quantity
895 boxes (25 cassettes per box)
Official record key
device-enforcement:Z-2440-2012

Official wording

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).

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The values reported for PCO2 by BP7561 B-Lac cassettes are biased at high concentrations when used at altitudes above 2800 feet (853 meters).