Radiometer Lactate Membrane Units Recalled for Enzyme Residue
Radiometer America Inc. is recalling Lactate Membrane units for the E7077 Electrode due to potential enzyme residue that may cause inaccurate test results.
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 2/5 (Moderate).
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, and the hazard involves potential test result bias rather than direct physical injury or reported illness, fitting the criteria for moderate severity.
Plain-English summary
Radiometer America Inc. is recalling Lactate Membrane units intended for use with the E7077 Electrode. These units are used for in vitro testing of whole blood samples. The recall involves 13,632 boxes containing four membranes each, with part numbers ranging from 942-066 R1741 to R1869.
The recall was initiated because some membranes may have enzyme residue on the outer membrane. This residue may cause an initial negative bias on the reported Lactate result when the membrane is replaced. The affected products were distributed nationwide, including in Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, the District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia.
Healthcare facilities and users of these products should stop using the affected Lactate Membrane units and contact Radiometer America Inc. for instructions on return or replacement. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood.
- Manufacturer
- Radiometer America 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 (1)
- Part Number: 942-066 R1741 to R1869
Distribution
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