Beckman Coulter DxU Analyzers Recalled for Potential Rust-Related Diagnostic Errors
Beckman Coulter is recalling DxU 850m/840m Microscopy Analyzers (254 units) due to potential rust in the cannula component, which may cause erroneous test results. The recall affects units distributed in the US and multiple international locations.
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: This is an FDA Class II recall without reported illnesses or injuries. The hazard—potential rust causing erroneous diagnostic results—is theoretical and has not resulted in confirmed adverse events. Per the rubric, risk-of-harm products where injury has not yet been reported score 3.
Plain-English summary
Beckman Coulter, Inc. is recalling the DxU 850m/840m Microscopy Analyzers, Part Numbers C49513 and C76947. All serial numbers of these analyzers are included in the recall.
The cannula, a component in the Flowcell and iQClear Rinse Waste Well Assembly, may rust over time. Rust formation has the potential to generate erroneous results in test analysis.
The recall affects 254 units that have been distributed in the United States and internationally, including Australia, Brazil, Canada, China, France, Germany, Ghana, India, Israel, Italy, Lebanon, Lithuania, Mexico, Panama, Qatar, Romania, Saudi Arabia, Spain, Taiwan, and the United Kingdom.
The recalled product
- Product
- Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
- Manufacturer
- Beckman Coulter, Inc.
- Hazard
- Affected units
- 254
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 (5)
- C49513
- UDI/DI 15099590748647
- C76947
- UDI/DI 15099590748654
- All serial numbers
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 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 4 products in this recall →Related recalls
Same manufacturer · Beckman Coulter, Inc.
See all →- SevereBeckman Coulter IQ200 Hematology Analyzers Recalled for Check Valve Defect
FDA (Devices) · 2026-10-21
- SevereBeckman Coulter DxU 840m and 850m Iris Recalled for Check Valve Defect
FDA (Devices) · 2026-10-21
- 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 500 AU Analyzer Software Defect Recall
FDA (Devices) · 2026-08-26
Same hazard · rust
See all →- HighREV 2 Flowcell Capsule Spare Recalled for Potential Rust and Erroneous Results
FDA (Devices) · 2024-01-31
- HighBeckman Coulter iQ200 Analyzers Recalled for Potential Rust and Diagnostic Errors
FDA (Devices) · 2024-01-31
- HighCranial Hand Drill recalled due to rust on chuck components
FDA (Devices) · 2023-05-31
- HighTransseptal Needles Recalled Due to Rust Contamination Risk
FDA (Devices) · 2021-11-24
- ModerateTriMed Peg Guide Extender Recalled Due to Rusting Spring Hazard
FDA (Devices) · 2019-11-20
Similar recalls
- SevereBeckman Coulter DxU 840m and 850m Iris Recalled for Check Valve Defect
FDA (Devices) · 2026-10-21
- HighBeckman Coulter UniCel DxH 800 Recalled for Potential Data Errors
FDA (Devices) · 2017-05-31
- HighBeckman Coulter Recalls UniCel DxH 800 and DxH 600 Hematology Analyzers
FDA (Devices) · 2013-11-13
- ModerateBeckman Coulter Recalls UniCel DxH Analysis Systems for Optical Defect
FDA (Devices) · 2014-07-02
- HighBeckman Coulter Recalls UniCel DxH Analysis Systems for Optical Degradation
FDA (Devices) · 2014-07-02
- HighBeckman Coulter Recalls UniCel DxH 800 Cellular Analysis System
FDA (Devices) · 2017-01-18