Beckman Coulter AQUIOS CL Flow Cytometer Software Export Defect Recall
Beckman Coulter is recalling AQUIOS CL Flow Cytometers because the software's Export feature incorrectly handles Tetra Combo CRD files.
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, and the source text describes a software export defect without reporting any specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Beckman Coulter Inc. is recalling the AQUIOS CL Flow Cytometer, Reference number B30166, equipped with Software Versions 2.0 and 2.0.1. The recall involves 188 units total, with 24 units distributed in the United States and the remainder distributed worldwide in various countries.
The recall was initiated because the Export feature located in the Results area of the AQUIOS System software is not correctly exporting Tetra Combo CRD files. This defect affects the in vitro diagnostic flow cytometric applications for which the device is intended.
Users of the affected devices should contact Beckman Coulter for further instructions regarding the software defect.
The recalled product
- Product
- AQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1 Product Usage: The AQUIOS CL Flow Cytometer is intended for use with in vitro diagnostic flow cytometric applications using up to four fluorescent detection channels using a blue (488 nm) laser, two…
- Manufacturer
- Beckman Coulter Inc.
- Hazard
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)
- All
Distribution
Distributed nationwide across the United States.
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 · software defect
See all →- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uMI 550 PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModeratePhilips SmartPath to MR 7700 Recalled for Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uCT 550 CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateBeckman Coulter Recalls AQUIOS CL Flow Cytometer Due to Software Error
FDA (Devices) · 2017-09-27
- HighBeckman Coulter AQUIOS CL Flow Cytometer Recalled for Sample Misidentification Risk
FDA (Devices) · 2017-11-22
- ModerateBeckman Coulter Recalls AQUIOS CL Flow Cytometers Due to Carousel Misalignment
FDA (Devices) · 2016-10-05
- HighBeckman Coulter AQUIOS CL Flow Cytometer System Recalled for Sample ID Errors
FDA (Devices) · 2018-04-18
- SevereBeckman Coulter Flow Cytometers Recalled for Signal Loss Defect
FDA (Devices) · 2018-11-28
- ModerateBeckman Coulter Recalls AQUIOS Lyse Reagent Kit for Increased Flags
FDA (Devices) · 2016-11-30