Beckman Coulter Recalls AQUIOS CL Flow Cytometer Due to Software Error
Beckman Coulter is recalling AQUIOS CL Flow Cytometer systems because a software configuration error may cause the device to draw samples from the wrong tube, resulting in incorrect laboratory values.
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 incorrect diagnostic values due to a software configuration error, which is a significant quality issue but does not involve a direct physical injury mechanism like fire or choking, nor are there reports of hospitalization or death.
Plain-English summary
Beckman Coulter Inc. is recalling the AQUIOS CL Flow Cytometer System, an in vitro diagnostic device intended for immunophenotyping. The recall involves 213 units worldwide, including 34 units in the United States. The devices were distributed in the US and numerous international locations, including Canada, Australia, and various countries in Europe, Africa, and South America.
The recall was initiated because an incorrect setting using a proprietary software configuration tool can cause the Sample Prep Probe to draw aspirant from the wrong tube in a cassette. This error manifests as incorrect values being reported for some patient samples. The recall covers all software versions and specific serial numbers listed in the agency documentation.
Healthcare facilities and laboratories should contact Beckman Coulter for instructions on how to address the software configuration issue. The source text does not specify a direct action for individual patients, but the error affects the accuracy of diagnostic results.
The recalled product
- Product
- AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping.
- 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 (20)
- All software versions.
- Serial numbers - BA30048
- AY20032
- BA01007
- AZ19046
- AZ12030
- BA25046
- BA05011
- AY51072
- BA01002
- AZ15044
- BA30049
- BA30050
- BA05015
- AZ19047
- BA18029
- AY47071
- AZ15038
- BA23036
- BA23035
Distribution
Distributed nationwide across the United States.
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