Beckman Coulter Recalls AQUIOS CL Flow Cytometers Due to Carousel Misalignment
Beckman Coulter is recalling AQUIOS CL Flow Cytometers because the reagent carousel can misalign and damage the prep probe.
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 mechanical damage to the device (carousel misalignment and probe damage) rather than direct patient injury or a high-risk biological pathogen, fitting the criteria for a moderate severity recall.
Plain-English summary
Beckman Coulter Inc. is recalling the AQUIOS CL Flow Cytometer, Catalog No. B30166. This device is intended for use with in vitro diagnostic flow cytometry applications using up to four fluorescent detection channels.
The recall is being issued because the use of the reagent carousel can lead to misalignment of the carousel and damage to the prep probe. A total of 148 units are affected, with 12 units distributed in the United States. The remaining units were distributed in various international locations including Canada, the United Kingdom, Germany, and Australia.
Healthcare facilities and users should stop using the affected devices and contact Beckman Coulter for further instructions on the recall.
The recalled product
- Product
- AQUIOS CL Flow Cytometer, Catalog No. B30166; Intended for use with in vitro diagnostic flow cytometry applications using up to four florescent detection channels.
- Manufacturer
- Beckman Coulter Inc.
Distribution
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