Beckman Coulter DxI 9000 immunoassay analyzer recalled for software-related motion errors
Beckman Coulter is recalling 61 DxI 9000 immunoassay analyzers worldwide due to a software error causing tray gripper motion errors that result in intermittent hard stops and delays in patient test results.
What this means for you
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 medical device recall where a software error causes operational failures (intermittent hard stops and delays) in a diagnostic analyzer. No injuries or illnesses have been reported, but the device's operational unreliability poses a risk to clinical workflow and patient testing. Per the rubric, this qualifies as a risk-of-harm product without reported injury, warranting High severity.
Plain-English summary
Beckman Coulter, Inc. is recalling 61 units of the DxI 9000 Access Immunoassay Analyzer (catalog number C11137). The analyzer is an in-vitro diagnostic device used for immunoassay testing. The recall affects devices distributed worldwide.
The recall was initiated due to a software error that causes an increase in tray gripper motion errors. These errors result in intermittent hard stops during device operation and delays in patient test results.
The affected devices have been distributed worldwide to the United States and to Australia, Austria, Brazil, Croatia, France, Germany, Hungary, India, Ireland, Italy, New Zealand, Portugal, Slovakia, Spain, Switzerland, Taiwan, China, and the United Kingdom. Affected units are identified by serial numbers from 300168 to 300228.
The recalled product
- Product
- Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 61
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: 300208
- 300201
- 300184
- 300185
- 300169
- 300225
- 300175
- 300172
- 300221
- 300209
- 300211
- 300212
- 300213
- 300214
- 300215
- 300210
- 300174
- 300226
- 300204
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Beckman Coulter, Inc.
See all →- 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
- High
- HighBeckman Coulter Access Total T4 Calibrator Recalled for Inaccurate Results
FDA (Devices) · 2026-04-29
Same hazard · software malfunction
See all →- HighAbbott Merlin pacemaker programmer may fail to terminate threshold test
FDA (Devices) · 2026-06-17
- HighMedtronic SynchroMed Flex Infusion Programmer Software Application
FDA (Devices) · 2026-05-20
- ModerateProtocol Configuration Tool software v1.3.0 for Hamilton AutoLys STAR
FDA (Devices) · 2026-04-29
- ModerateChange Healthcare Cardiology Hemo Software Unexpected Shutdown Risk
FDA (Devices) · 2025-07-09
- HighSiemens Interventional Fluoroscopic X-Ray System Software Communication Failure
FDA (Devices) · 2025-07-09