Beckman Coulter recalls DxC 500 AU Clinical Chemistry Analyzers (REF C63520) due to software issues that may cause delayed results after processing 250 racks. Affected units have specific serial numbers.
Due to a software issues, after the instrument processes 250 racks cumulatively, any subsequent racks with samples requiring rerun/reflex will be held in the Sample Handler's Buffer area and and error code "9000" will be reported. This issue may cause a delay of results.
Take action
Contact the company
📍Recalling firmBeckman Coulter Mishima K.K.454-32, Higashino; Nagaizumi-Cho · Sunto-Gun, Japan
“Beckman Coulter DxC 500 AU Analyzer Recall: Software Error Causes Delayed Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54671-beckman-coulter-dxc-500-au-analyzer-recall-software-error-causes. Based on FDA recall #Z-2691-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2691-2024%22&limit=1).
Beckman Coulter Mishima K.K. recalled the DxC 500 AU Clinical Chemistry Analyzer, REF C63520, due to software issues that may delay patient results, the FDA said on July 10, 2024.
How to tell if you have it
Brand: Beckman Coulter
Product: DxC 500 AU Clinical Chemistry Analyzer
REF: C63520
Quantity: 24 analyzers
The hazard
Due to software issues, the analyzer may hold samples requiring reruns in the buffer area and report error code "9000" after processing 250 racks cumulatively. This issue may cause a delay of results.
Context
GovInfoNow's records show Beckman Coulter Mishima K.K. has had four other recalls since June 5, 2024. Other recent recalls include the AU480 Chemistry Analyzer recall on Aug. 3, 2026, and the DxC 700 AU Recall on Jan. 30, 2026. Additional similar product recalls include the DxC 500i Modules recall on July 15, 2026, and the UniCel Dxl 600 recall on Nov. 26, 2025.
How to tell if you have this one
Check if your DxC 500 AU Clinical Chemistry Analyzer has a serial number starting with 2023070010, 2023060005, or other listed numbers in the recall notice. The product is for in vitro diagnostic use only.
Brand
Beckman Coulter
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Serial Numbers
Verify your analyzer's serial number against the list of affected units provided in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 13 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - U.S. Nationwide distribution in the states of AL, CA, GA, HI, IL, MI, MN, MS, NE, NY, OR, PA and SC. The countries of Lebanon, South Africa.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Georgia, Hawaii, Illinois, Michigan, Minnesota, Mississippi, Nebraska, New York, Oregon, Pennsylvania, South Carolina.
Recall timeline
FDA published this recall 49 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-2691-2024 (July 10, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2691-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.