Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
BP7561 OPTI CCA-TS B-Lac Cassette (25 per box) Cassettes are Recalled by OPTI Medical Systems, Inc Due to The values reported for PCO2 by BP7561 B-Lac...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact OPTI Medical Systems, Inc directly.
Affected Products
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.
Quantity: 895 boxes (25 cassettes per box)
Why Was This 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).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About OPTI Medical Systems, Inc
OPTI Medical Systems, Inc has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report