Beckman Coulter Recalls UniCel DxI 800 Immunoassay Systems Due to Software Anomaly
Beckman Coulter is recalling UniCel DxI 800 Access Immunoassay Systems because a software anomaly may cause erroneous test results.
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 involves a risk-of-harm product (medical device) where the software anomaly may cause erroneous test results, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Beckman Coulter Inc. is recalling UniCel DxI 800 Access Immunoassay Systems. The affected units include part numbers 937100, A25288, A71456, and A25285. The recall involves 2,442 units total, with 784 units distributed in the United States and the remainder distributed worldwide.
The recall was initiated because Beckman Coulter received seven reports of a software anomaly for the UniCel Dxl Immunoassay Systems. If undetected, this anomaly may cause erroneous test results. The device is an in vitro diagnostic used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Healthcare facilities and laboratories should contact Beckman Coulter for instructions on how to address the software anomaly and ensure accurate test results.
The recalled product
- Product
- UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: A25288; Dxl 800 with spot B: A71456; Dxl 800 Reconditioned: A25285. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative…
- 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 (4)
- Part Numbers: Dxl 800: 937100
- Dxl 800 Remanufactured: A25288
- Dxl 800 with spot B: A71456
- Dxl 800 Reconditioned: A25285.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Beckman Coulter Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →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 · erroneous test results
See all →- HighVITROS XT 7600 Chemistry Analyzer Software Anomaly Causing Erroneous Test Results
FDA (Devices) · 2025-07-09
- HighClinical Laboratory Quality Control Device Recalled for Diluent Assembly Error
FDA (Devices) · 2024-04-03
- HighLaboratory performance verifier recalled for mismatched diluent assembly
FDA (Devices) · 2024-04-03
- HighVITROS 3600 Immunodiagnostic Systems May Cause Aspiration During Sample Processing
FDA (Devices) · 2024-03-13
- HighVITROS XT7600 System Aspiration Risk During Sample Processing
FDA (Devices) · 2024-03-13
Similar recalls
- ModerateBeckman Coulter Recalls UniCel Dxl 800 Access Immunoassay Systems
FDA (Devices) · 2012-11-28
- HighBeckman Coulter UniCel DxI 600 and 800 Systems Recalled for Software Error
FDA (Devices) · 2019-04-10
- HighBeckman Coulter Recalls UniCel Dxl 600 Access Immunoassay Systems
FDA (Devices) · 2012-11-28
- HighBeckman Coulter Recalls UniCel DxC Immunoassay Systems Due to Field Modifications
FDA (Devices) · 2012-11-28
- ModerateBeckman Coulter Recalls UniCel DxI 600 Access Immunoassay System Analyzer
FDA (Devices) · 2014-02-26
- ModerateBeckman Coulter Recalls Sample Probe Cables for Immunoassay Systems
FDA (Devices) · 2014-10-01