Clinical Chemistry Analyzer Fails to Track Assay Expiration Dates After Software Update
A software issue in the DxC 500 AU analyzer prevents correct tracking of assay expiration dates after software upgrades. Expired assays may be used, potentially producing inaccurate 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: Class II recall of a clinical device with a functional defect that could result in inaccurate patient test results. No illnesses or injuries reported. Fits the rubric criterion for score 3: risk-of-harm product where injury has not yet been reported.
Plain-English summary
The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer with software versions 1.4, 1.4.1, 1.4.2, or 1.4.3 is being recalled due to a software defect in the expiration date tracking system.
When the instrument is upgraded from an earlier software version, it fails to correctly update the onboard stability dates (open expiration dates) for assays that were already loaded on the instrument before the upgrade. As a result, assays that have actually expired may continue to display as valid, and laboratory staff may unknowingly use expired assays for patient sample analysis. This can lead to inaccurate or erroneous patient test results. The software defect does not affect assays loaded after the upgrade, nor does it impact newly installed instruments.
The recall affects 56 DxC 500 AU instruments distributed across multiple U.S. states and several countries. Laboratory facilities with affected instruments should verify the current expiration status of all assays in use and contact Beckman Coulter for information about software updates or other remediation steps.
The recalled product
- Product
- DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.
- Category
- Medical Device
- Affected units
- 56
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)
- Software Versions: V1.4
- V1.4.1
- V1.4.2
- V1.4.3 REF/UDI-DI/Serial Numbers: C63519/14987666545058/2024090170
- C63520/14987666545065/2024070116
- 2023070009
- 2024010038
- 2024010035
- 2024050072
- 2024040056
- 2024030049
- 2024020046
- 2024070111
- 2024030051
- 2024030052
- 2024010033
- 2023090015
- 2024060103
- 2024060104
- 2024060101
Distribution
Related recalls
Same hazard · inaccurate results
See all →- ModerateRadiometer ABL90 FLEX Analyzers Recalled for Inaccurate Results
FDA (Devices) · 2026-10-21
- SevereInstrumentation Laboratory Recalls HemoslL AcuStar HIT-lgG In Vitro Diagnostic
FDA (Devices) · 2026-10-21
- 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
- HighHealthmark Protein Test Recalled Due to Expired Ingredient
FDA (Devices) · 2026-09-02
Similar recalls
- 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
- HighClinical Chemistry Analyzer Software Bugs May Cause Erroneous Patient Results
FDA (Devices) · 2024-08-07
- ModerateClinical Chemistry Analyzer Software Issue Causes Delayed Results
FDA (Devices) · 2024-08-28
- HighBeckman Coulter DxC 500 AU Clinical Chemistry Analyzer Recall
FDA (Devices) · 2025-05-07
- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14