Beckman Coulter Recalls AQUIOS Lyse Reagent Kit for Increased Flags
Beckman Coulter is recalling the AQUIOS Lyse Reagent Kit because it may cause increased notifications and flags on AQUIOS CL systems, potentially delaying 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, but the source text describes a performance issue leading to delayed results and re-runs rather than direct physical injury or hospitalization, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Beckman Coulter Inc. is recalling the AQUIOS Lyse Reagent Kit, Catalog No. B23538. This product is used as part of the AQUIOS flow cytometer system to prepare whole blood samples for the analysis of white blood cells.
The recall was initiated because the reagent kit may lead to an increased generation of notifications and flags when used on the AQUIOS CL while running the AQUIOS Tetra application. This issue could result in an increase in the number of samples requiring review and re-runs, which may cause a delay in the reporting of results. Depending on the age of the specimen, a new blood specimen may be required for analysis.
A total of 2,367 units were distributed worldwide, including 207 units in the United States. The affected products were distributed in the US and in Belgium, Botswana, Canada, Chile, Columbia, Czech Republic, Denmark, Finland, France, Germany, Ghana, Italy, Malaysia, Netherlands, Poland, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, United Kingdom, and Zambia. Affected lot codes are 6040014K and 6040015K. Users should contact Beckman Coulter for further instructions on how to proceed with affected samples.
The recalled product
- Product
- AQUIOS Lyse Reagent Kit, Catalog No. B23538 Product Usage: AQUIOS Lysing Reagent Kit is used as part of the AQUIOS flow cytometer system. The kit consists of two reagents used by AQUIOS flow cytometers to prepare whole blood samples for analysis of white blood cells.
- 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 (1)
- 6040014K 6040015K
Distribution
Distributed nationwide across the United States.
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