Beckman Coulter Recalls Access Immunoassay Reaction Vessels Due to Motion Errors
Beckman Coulter is recalling Access Immunoassay Reaction Vessels due to intermittent wash carousel motion errors affecting specific lots.
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 does not report any hospitalizations, injuries, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Beckman Coulter is initiating a recall for Access Immunoassay Systems Reaction Vessels. This recall includes the Acess/Access 2 Immunoassay Systems, SYNCRON LXi 725 Clinical System, and UniCel DxC 600i SYNCHRON Access Clinical System. The affected units are identified by Part Number 81901 and Lot Numbers 13181168-13341170.
The recall is being conducted because Beckman Coulter has observed an intermittent increase in "Wash Carousel Motion Errors" associated with specific lots of these Reaction Vessels. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
A total of 16,154 units were distributed worldwide, including nationwide in the USA and internationally to Canada, Japan, India, Hong Kong, Guatemala, China, Brazil, Brunei Darussalam, Costa Rica, El Salvador, Jordan, Malaysia, Mexico, Panama, Philippines, South Africa, Taiwan, Thailand, Trinidad and Tobago, United Arab Emirates, Venezuela, and Viet Nam. Users should contact Beckman Coulter for further instructions regarding the recall.
The recalled product
- Product
- Access Immunoassay Systems Reaction Vessels. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- Affected units
- 16,154
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 (2)
- Part Number 81901
- Lot Numbers: 13181168-13341170.
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Beckman Coulter Inc.
See all →- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- HighBeckman Coulter DxC 500 AU Analyzer Software Defect Recall
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- High
Same hazard · mechanical failure
See all →- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
Similar recalls
- ModerateBeckman Coulter Recalls Access 2 Immunoassay Systems Due to Circuit Board Defect
FDA (Devices) · 2017-04-12
- HighBeckman Coulter Recalls Access Immunoassay Systems Due to Pulley Defects
FDA (Devices) · 2013-01-02
- HighBeckman Coulter Recalls Access 2 Immunoassay System Due to Fuse Defect
FDA (Devices) · 2013-11-20
- HighBeckman Coulter Recalls UniCel DxC 600i Synchron Access Clinical Systems
FDA (Devices) · 2013-04-10
- ModerateBeckman Coulter Recalls UniCel DxI 600 Access Immunoassay System Analyzer
FDA (Devices) · 2014-02-26
- ModerateBeckman Coulter Access 2 Immunoassay System Analyzer Recalled for Non-Conforming Bushings
FDA (Devices) · 2014-02-26