DxI 9000 Access Immunoassay Analyzer Encoder Wheel Misalignment
Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer (206 units) because an encoder wheel misalignment on the motor shaft can cause the instrument to stop and delay patient 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 device malfunction poses a risk of harm through diagnostic delays in patient testing. Although this is a Class II recall with no reported injuries or deaths, the explicit statement of 'high safety risk' and the potential for delayed patient results in clinical laboratory settings meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' warranting a High severity score.
Plain-English summary
Beckman Coulter, Inc. is recalling the DxI 9000 Access Immunoassay Analyzer (Catalog Number C11137) distributed nationwide and globally. The analyzer is used in clinical laboratories to perform immunoassays for patient testing.
The recall is due to a misalignment of the encoder wheel on the motor shaft in certain units. This misalignment can lead to increased slippage errors, causing the instrument to stop functioning. When the analyzer stops, patient test results are delayed, posing a high safety risk to patients who depend on timely diagnostic information.
The affected units are identified by specific serial numbers listed in the recall notice. Healthcare facilities using affected instruments should immediately contact Beckman Coulter or their service representatives. Corrective action and replacement devices are available from the manufacturer.
The recalled product
- Product
- DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 206
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 (20)
- UDI-DI: 15099590732103
- Serial Numbers: 300116-300117
- 300123-300124
- 300126
- 300128-300139
- 300141-300145
- 300147- 300158
- 300160-300164
- 300166-300179
- 300181-300183
- 300186
- 300188-300195
- 300197-300207
- 300209-300250
- 300252- 300256
- 300258-300259
- 300261
- 300263- 300264
- 300266-300277
- 300279-300290
Distribution
Distributed nationwide across the United States.
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 · device malfunction
See all →- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
- ModerateMedline recalls CONMED AirSeal Access Port kits due to pressure alert issues
FDA (Devices) · 2026-10-21
- ModerateMedline Recalls Convenience Kits Containing CONMED AirSeal Access Ports
FDA (Devices) · 2026-10-21
Similar recalls
- HighBeckman Coulter DxI 9000 Analyzer wash wheel mixer defect may prevent operation
FDA (Devices) · 2025-03-19
- ModerateDxI 9000 Access Immunoassay Analyzer software version 1.20 recall
FDA (Devices) · 2025-06-18
- HighBeckman Coulter DxI 9000 immunoassay analyzer recalled for software-related motion errors
FDA (Devices) · 2025-02-12
- HighImmunoassay analyzers recalled over dilution factor anomaly affecting patient results
FDA (Devices) · 2025-10-29
- HighBeckman Coulter DxI 9000 Access analyzer software causes delayed test results
FDA (Devices) · 2024-08-21
- ModerateAccess 2 Immunoassay Analyzer motor alignment issue may delay results
FDA (Devices) · 2025-03-26