Clinical Chemistry Analyzer Recalled for Software Defect in Test Result Calculation
Beckman Coulter is recalling certain DxC 500 AU Clinical Chemistry Analyzers due to a software defect that prevents calculated test results from being recalculated when constituent tests are rerun, potentially delaying patient result reporting.
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 a Class II medical device with a software defect affecting diagnostic result calculation and reporting. No illnesses or injuries have been reported. Per the FDA severity rubric, risk-of-harm products without documented injury are classified as High.
Plain-English summary
Beckman Coulter Inc. is recalling DxC 500 AU Clinical Chemistry Analyzers with software versions V1.3, V1.4, V1.4.1, V1.4.2, and V1.4.3. The analyzer is an automated device used in clinical laboratories to measure patient samples and calculate diagnostic test results.
A software defect in these versions prevents the analyzer from recalculating results when constituent tests are rerun. When tests are rerun manually by operators or automatically by system rules, the analyzer fails to regenerate calculated results based on the new test data. Instead, it reports the calculated result from the original tests. This defect may cause delays in reporting patient results.
The recall affects 143 analyzers distributed worldwide: 74 units in the United States and 69 units internationally to countries including Australia, Belgium, Canada, France, Germany, India, Italy, South Korea, Netherlands, Philippines, Poland, and others.
Facilities using affected analyzers should contact Beckman Coulter for information about software updates. Users can identify affected devices by checking the catalog numbers (C63519 and C63520) and serial numbers listed on the FDA recall notice.
The recalled product
- Product
- DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with…
- Manufacturer
- Beckman Coulter Inc.
Distribution
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 · software defect
See all →- ModerateIntelerad IntelePACS Software Recalled for Image Display Mismatch
FDA (Devices) · 2026-10-21
- 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
- ModeratePhilips MR 7700 Software Upgrade Recalled for Incorrect DTI Data
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uMI Panvivo S PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
Similar recalls
- HighBeckman Coulter DxC 500 AU Clinical Chemistry Analyzer Recall
FDA (Devices) · 2025-05-07
- ModerateBeckman Coulter DxC 500 AU Chemistry Analyzer Software Calibration Error
FDA (Devices) · 2025-05-21
- 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
- ModerateClinical Chemistry Analyzer Software Issue Causes Delayed Results
FDA (Devices) · 2024-08-28
- HighBeckman Coulter AU5800 Clinical Chemistry Analyzer Recalled for Software Error
FDA (Devices) · 2013-05-01