Lower riskMedical device recall · FDA · Published February 26, 2025
Beckman Coulter DxC 500 AU Analyzer Software Defect May Delay Patient Results
Beckman Coulter recalls DxC 500 AU Clinical Chemistry Analyzers with specific software versions due to a defect that may cause delays in reporting patient test results when recalculating results.
Beckman Coulter has determined that device software versions V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3. have a defect due of which, when all constituent tests of a calculated result are rerun, either manually ordered by the operator at the analyzer or automatically triggered by predefined rules in System Configuration, the calculated result will not be recalculated using the constituent tests rerun results. The system will report only the calculated result using the initial constituent tests results to the operator and LIS/Remisol. The issue was identified by Beckman Coulter internal engineering testing. The defect may cause a delay in reporting patient results.
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Contact the company
📍Recalling firmBeckman Coulter Inc.250 S Kraemer Blvd · Brea, CA 92821-6232
✎ GovInfoNow plain-language explainer
Beckman Coulter is recalling certain DxC 500 AU Clinical Chemistry Analyzers that have software versions V1.3 through V1.4.3. This defect can cause delays in reporting patient results when the system recalculates test results after rerunning constituent tests. Read more at govinfonow.com/recall/52743-beckman-coulter-dxc-500-au-analyzer-software-defect-may-delay.
“Beckman Coulter DxC 500 AU Analyzer Software Defect May Delay Patient Results.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52743-beckman-coulter-dxc-500-au-analyzer-software-defect-may-delay. Based on FDA recall #Z-1517-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1517-2025%22&limit=1).
The FDA announced on Feb. 26, 2025, that Beckman Coulter Inc. is recalling DxC 500 AU Clinical Chemistry Analyzers due to a software defect that may delay patient test results. The agency issued recall number Z-1517-2025 for the Class II voluntary recall.
According to the FDA, the device's software defect causes calculated results to remain unchanged when constituent tests are rerun, potentially delaying the reporting of patient results. The issue was identified by Beckman Coulter internal engineering testing.
Context
GovInfoNow's records show Beckman Coulter has issued 132 other recalls since June 20, 2017. Recent similar product recalls include the AU480 Chemistry Analyzer recall on Aug. 3, 2026, and the Beckman Coulter AU5800 Chemistry Analyzer recall on Jan. 30, 2026.
How to tell if you have this one
Check for catalog numbers C63519 or C63520 with UDI codes 14987666545058 or 14987666545065. The device is identified by specific serial numbers listed in the recall notice.
Brand
Beckman Coulter
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version on your DxC 500 AU Clinical Chemistry Analyzer to ensure it is not V1.3, V1.4, V1.4.1, V1.4.2, or V1.4.3.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 24 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide Distribution: U.S. (nationwide) to states of: AL, CA, CO, GA, ID, IL, IN, LA, MA, AI, MN, MS, MT, NC, NM, NV, NY, OK, OR, PA, PR, SC, TN, TX, WA, and WI; O.U.S. (foreign) to countries of: Australia, Belgium, Bosnia/Herzegovina,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Colorado, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Minnesota, Mississippi, Montana, Nevada, New Mexico, New York, North Carolina, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Washington, Wisconsin.
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
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-1517-2025 (February 26, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1517-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.