Beckman Coulter Urine Chemistry Controls May Produce False Positive Results
Beckman Coulter IRISPEC urine chemistry control materials may intermittently fail to detect negative glucose, producing false positive control results that could delay patient test reporting.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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: FDA Class III device with documented customer complaints of intermittent control failures, but no reported patient illnesses or injuries. While false positive controls could delay diagnosis of serious conditions, the lack of actual harm and intermittent nature support a Moderate rating.
Plain-English summary
Beckman Coulter, Inc. has issued a recall of IRISPEC CA/CB/CC Urine Chemistry Controls (Catalog Numbers REF 800-7211 and 800-7702) due to intermittent failures in the negative glucose control component. When used with iChemVELOCITY Urine Chemistry Strips (part numbers 800-7204 and 800-7212) on iChemVELOCITY Analyzers, these materials may produce false positive control results.
Approximately 5,589 units have been distributed worldwide, with affected lot numbers 432-24 and higher. The false positive control results may delay the reporting of patient test results.
In the worst-case scenario, delays in test result reporting could postpone the diagnosis or treatment of metabolic disorders, kidney function abnormalities, urinary tract infections, and liver function conditions.
The recalled product
- Product
- Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 5,589
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)
- UDI/DI 10837461002611
- Lot Numbers: 432-24 and higher
Distribution
Distribution scope not specified by the agency.
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