Beckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
Beckman Coulter is recalling DxC 500i Clinical Analyzer Modules due to a software defect that may cause erroneous 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 recall involves a risk-of-harm product (medical device) where erroneous patient test results could lead to harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Beckman Coulter Inc. is recalling specific DxC 500i Clinical Analyzer Modules that are running software version 1.5 or lower. The affected modules include the DxC 500 AU Module w/ISE (Part Number C63522), the DxC 500 AU Module (Part Number C63521), and the Access 2 Module (Part Number C13252). These products were distributed worldwide and across the United States.
The recall is due to a software defect in the Parameter Package (PP) import logic. When a new Parameter Package version is imported to a system that already has an existing Parameter Package onboard, the logic overwrites all predefined calculated test rules, including those previously modified by the user. This causes user-customized rules to revert silently to their default expressions without an explicit error notification, potentially generating erroneous patient test results. The issue does not affect new installations.
Healthcare facilities using these specific analyzer modules with software version 1.5 or lower should contact Beckman Coulter Inc. for instructions on how to resolve the software defect.
The recalled product
- Product
- Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522; 2) DxC 500 AU Module, DxC 500i, Part Number C63521; 3) Access 2 Module, DxC 500i, Part Number C13252; DxC 500 AU Clinical…
- 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 (6)
- 1) Part Number C63522
- UDI/DI 14987666545089
- 2) Part Number C63521
- UDI/DI 14987666545072
- 3) Part Number C13252
- UDI/DI 15099590742331.
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
- SevereBeckman Coulter MicroScan Panel Update DVD Kits Recalled
FDA (Devices) · 2026-08-12
- High
Same hazard · software defect
See all →- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uCT 550 CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uMI Panvivo S PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModeratePhilips SmartPath to MR 7700 Recalled for Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
Similar recalls
- HighBeckman Coulter DxC 500 AU Analyzer Software Defect Recall
FDA (Devices) · 2026-08-26
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- HighClinical analyzer modules recalled over dilution factor software anomaly affecting results
FDA (Devices) · 2025-10-29
- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- HighClinical Chemistry Analyzer Recalled for Software Defect in Test Result Calculation
FDA (Devices) · 2025-04-09
- ModerateBeckman Coulter DxC 500 AU Chemistry Analyzer Software Calibration Error
FDA (Devices) · 2025-05-21