Lower riskMedical device recall · FDA · Published September 2, 2026
DxC 500i Clinical Analyzer Modules May Show Incorrect Test Results Due to Software Issue
Beckman Coulter recalls DxC 500i Clinical Analyzer Modules with specific part numbers due to a software issue that can cause test results to show falsely elevated values when plasma samples are tested.
Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system default, a subsequent configuration change and activation of the draft configuration in the System Configuration page may cause the analyzer to revert the test units to the system default setting without notifying the user. The system does Pre-Review Reminders Include OII and CDRHRecallGroup@fda.hhs.gov in any discussions on change/elevation of recalls to Class I classification and situations involving additional public communications (FDA and/or firm issued). Post-Review Reminders Final Check: Ensure your documentation accurately reflects the final recommendation prior to signature. Complete CTS: Recall Product tab, Additional Recall Event Info, Regulation, and Act. Upload PDFs of Consult, Review Memo, and Classification Letter for Class I Recall in DocMan. [Click to enter extra reminder]To add reminders, type the reminder in the text field to the left then press the Tab key. Doc ID 03534.05.06 2 of 8 not provide a warning or notification to alert the user that the configured units have reverted to the default units. This issue can result in falsely elevated reported results.
“DxC 500i Clinical Analyzer Modules May Show Incorrect Test Results Due to Software Issue.” GovInfoNow, updated October 21, 2026. https://govinfonow.com/recall/1629442-beckman-coulter-inc-recalls-dxc-500i-clinical-analyzer-modules-1. Based on FDA recall #Z-0083-2027 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0083-2027%22&limit=1).
The FDA announced on Sept. 2, 2026, that Beckman Coulter Inc. is recalling DxC 500i Clinical Analyzer Modules due to a software issue that may cause falsely elevated reported results. The agency classified the recall as Class II.
How to tell if you have it
DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522
DxC 500 AU Module, DxC 500i, Part No. C63521
Access 2 Module, DxC 500i, Part No. C13252; Software version 1.3.5 or earlier
UDI-DI 14987666545089
UDI-DI 14987666545072
UDI-DI 15099590742331
The hazard
According to the FDA, a software defect may cause the analyzer to revert test units to system defaults without notifying the user when testing plasma samples. This issue can result in falsely elevated reported results.
Context
GovInfoNow's records show Beckman Coulter, Inc. has 133 other recalls on record since June 20, 2017. Other recent recalls of similar products include Beckman Coulter DxC 500i Modules with Software 1.5 Risk: Erroneous Test Results (July 15, 2026), Beckman Coulter MicroScan LabPro V5.03 Panel Update 11 DVD Kit: Incorrect Algorithms May Affect Test Results (June 26, 2026), and Beckman Coulter Access Total T4 Calibrator Recall: False Low Results Risk Incorrect Treatment (March 16, 2026). Other recent recalls of similar products include Beckman Coulter REMISOL Advance Software Issue: Incorrect Test Results (April 29, 2026), Beckman Coulter DxC 700 AU Recall: Delay in Results May Cause Diagnosis Delays (Jan. 30, 2026), and AU480 Chemistry Analyzer May Show Error Message Causing Delay in Patient Results (Aug. 3, 2026).
How to tell if you have this one
Check for part numbers C63522, C63521, or C13252 with software version 1.3.5 or earlier. The recall includes specific UDI-DI numbers: 14987666545089, 14987666545072, and 15099590742331.
Brand
Beckman Coulter
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide - US Nationwide distribution.
Recall number
Product, codes & lots
Z-0083-2027
DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, DxC 500i, Part No. C63521 3. Access 2 Module, DxC 500i, Part No. C13252; Software version 1.3.5 or earlier. 1. UDI-DI 14987666545089 2. UDI-DI 14987666545072 3. UDI-DI 15099590742331
Z-0084-2027
DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE, Part No. C63520; Software version 1.4.5 or earlier. 1. UDI-DI 14987666545058 2. UDI-DI 14987666545065
Based on the official FDA remedy
What to do — step by step
Check Module Part Number
Identify the part number on your DxC 500i Clinical Analyzer Module to see if it matches C63522, C63521, or C13252.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide - US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 42 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0083-2027 (September 2, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0083-2027 to see it in context.
Plain-language summary written by qwen3:4b on October 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.