Beckman Coulter Recalls Active Renin IRMA Kit Due to Stability Issues
Beckman Coulter is recalling the Active Renin IRMA Kit because decreased stability in coated tubes may cause falsely elevated 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. The hazard involves inaccurate test results (falsely elevated) due to stability issues, which is a significant quality defect but does not involve direct physical injury or death, fitting the Moderate category for labeling/quality errors without reported harm.
Plain-English summary
Beckman Coulter Inc. is recalling the Active Renin IRMA Kit, Part Number DSL25100. This immunoradiometric assay kit is intended for in vitro diagnostic use to measure Renin in plasma. The recall involves 216 units total, with 6 units distributed in the United States.
The recall was initiated because Beckman Coulter confirmed that the kit may exhibit a decrease in stability of the coated tubes. As a result, quality control and patient sample results may be falsely elevated by up to 72%. The affected lots are 110919D, 111017C, 111017D, 111114C, and 111212C.
The product was distributed worldwide, including in the United States (Ohio, Connecticut, California) and various international locations. Users should stop using the affected kits and contact Beckman Coulter for further instructions.
The recalled product
- Product
- Active Renin IRMA Kit, Part Number DSL25100 Product Usage: The Renin IRMA; DSL25100 immunoradiometric assay kit provides materials for the quantitative measurement of Renin in plasma. This assay is intended for in vitro diagnostic use.
- Manufacturer
- Beckman Coulter 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 (5)
- Lot # 110919D
- 111017C
- 111017D
- 111114C
- 111212C.
Distribution
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