OPTI Medical Systems Recalls BP7561 B-Lac Cassettes for Altitude Bias
OPTI Medical Systems is recalling BP7561 B-Lac cassettes because PCO2 readings are biased at high altitudes.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that could lead to inaccurate clinical measurements (PCO2 bias), which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
OPTI Medical Systems, Inc. is recalling 895 boxes of BP7561 OPTI CCA-TS B-Lac Cassettes. These cassettes are consumables used in the OPTI CCA-TS Analyzer for in vitro measurements of blood gases and metabolites, including pH, PCO2, PO2, lactate, total hemoglobin, and oxygen saturation in heparinized whole blood samples.
The recall is due to a defect where the values reported for PCO2 are biased at high concentrations when the cassettes are used at altitudes above 2,800 feet (853 meters). This issue may affect the accuracy of clinical measurements in high-altitude settings.
The affected cassettes were distributed worldwide, including nationwide in the United States and in numerous international countries. Users should stop using the affected cassettes and contact OPTI Medical Systems for further instructions.
The recalled product
- 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…
- Manufacturer
- OPTI Medical Systems, Inc
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot numbers: 110650
- 114650
- 114651
- 114652
- 114653
- 116650
- 116652
- 117650
- 118651
- 121650
- 121651
- 122652
- 122653
- 122654
- 122655
- 122656
- 122657
- 123654
- 123655
- 124650
Distribution
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