Beckman Coulter AQUIOS CL Flow Cytometer Recalled for Sample Misidentification Risk
Beckman Coulter is recalling 268 AQUIOS CL Flow Cytometers because the system may duplicate sample requests, leading to sample misidentification when connected to a Laboratory Information System.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves sample misidentification, which poses a risk of harm to patients through incorrect diagnostic results, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Beckman Coulter Inc. is recalling 268 units of the AQUIOS CL Flow Cytometer, Catalog No. B30166. The device is an in vitro diagnostic instrument intended for immunophenotyping and is used with specific monoclonal antibody reagents and software. The recall is due to a software defect where the system may duplicate sample requests, which can lead to sample misidentification when the device is connected to a Laboratory Information System (LIS).
The affected units were distributed worldwide, including in the United States (AZ, CA, CO, FL, GA, IL, IN, KS, NC, NY, OR, PA, SC, TX, WA, and Puerto Rico) and in numerous international locations. The recall covers all existing software versions 2.0, 2.0.1, and 2.1. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
Healthcare facilities and laboratories using the AQUIOS CL Flow Cytometer should contact Beckman Coulter Inc. for instructions on how to resolve the issue. Users should verify sample identification protocols to prevent potential misidentification of patient samples.
The recalled product
- Product
- AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman Coulter Ireland Inc., Ireland. The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping. It is used in conjunction with the following…
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 268
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 (3)
- All existing software versions (2.0
- 2.0.1
- and 2.1).
Distribution
Related recalls
Same manufacturer · Beckman Coulter Inc.
See all →- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500 AU Analyzer Software Defect Recall
FDA (Devices) · 2026-08-26
- SevereBeckman Coulter MicroScan Panel Update DVD Kits Recalled
FDA (Devices) · 2026-08-12
Same hazard · sample misidentification
See all →- HighMedical Device Recall: ACL TOP Coagulation Analyzers for Sample Misidentification
FDA (Devices) · 2023-09-20
- HighLaboratory Automation System Firmware May Misidentify Patient Samples
FDA (Devices) · 2023-05-10
- HighLaboratory Automation Module Firmware May Cause Sample Misidentification
FDA (Devices) · 2023-05-10
- HighLaboratory automation module firmware may cause sample misidentification
FDA (Devices) · 2023-05-10
- HighDiagnostic System Software Defects Affecting Sample Processing and Test Accuracy
FDA (Devices) · 2022-11-30
Similar recalls
- HighBeckman Coulter AQUIOS CL Flow Cytometer System Recalled for Sample ID Errors
FDA (Devices) · 2018-04-18
- ModerateBeckman Coulter Recalls AQUIOS CL Flow Cytometer Due to Software Error
FDA (Devices) · 2017-09-27
- ModerateBeckman Coulter Recalls AQUIOS CL Flow Cytometers Due to Carousel Misalignment
FDA (Devices) · 2016-10-05
- ModerateBeckman Coulter AQUIOS CL Flow Cytometer Software Export Defect Recall
FDA (Devices) · 2017-05-10
- ModerateBeckman Coulter Recalls AQUIOS Lyse Reagent Kit for Increased Flags
FDA (Devices) · 2016-11-30
- HighFlow cytometers recalled over software that crashes during sample acquisition
FDA (Devices) · 2025-11-26