Radiometer pO2 Membrane Units Recalled Due to Incorrect Inner Solution
Radiometer America is recalling pO2 D999 membrane units because they were produced with the wrong inner solution, causing calibration failures.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a manufacturing error leading to calibration failure, which is a functional defect rather than a direct physical injury or high-risk pathogen exposure, fitting the criteria for moderate severity.
Plain-English summary
Radiometer America, Inc. is recalling pO2 D999 membrane units (ordering number 942-042, lot number R0971). The affected units are intended for in vitro testing of whole blood samples to measure partial pressure of oxygen (pO2). The recall involves 209 boxes containing 6 membranes each.
The company discovered that the specific lot was produced with the inner solution intended for pCO2 membrane units rather than pO2 units. While the solution is a similar salt solution, it contains glycerol. This glycerol can be reduced at the cathode, causing a sudden rise in zero current that leads the membrane unit to fail the subsequent Cal2 calibration.
The affected units were distributed worldwide, including nationwide in the United States (specifically noting Colorado, Connecticut, Georgia, Massachusetts, Missouri, and Mississippi) and in Canada. Users should stop using the affected membrane units and contact Radiometer America for further instructions.
The recalled product
- Product
- pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, OH 44145 pO2 membrane units, ordering number 942-042 Intended use is in vitro testing of samples of whole blood for pO2 (partial pressure of oxygen).
- Manufacturer
- Radiometer America Inc
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 (2)
- Part #: 942-042
- Lot #: R0971
Distribution
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