Lower riskMedical device recall · FDA · Published June 5, 2024
Beckman Coulter DxC 500 AU Analyzer Recall: Software Bugs May Cause Wrong Test Results
Beckman Coulter recalls DxC 500 AU Clinical Chemistry Analyzers with software bugs that could cause incorrect patient test results. No immediate action is needed but users should check for specific serial numbers.
There are two software bug issues with the analyzer. Issue 1: When a dedicated rack is reserved for calibration, after a calibration test has been placed and completed, the same rack may be used to place both a patient order and a calibration order. When a patient sample and a non-barcoded calibrator tube is processed on the rack, the calibration result will be reported as a patient result. Issue 2: calibration with expired calibrator. They both may cause erroneous patient results, but the probability of serious adverse health consequences or death is unlikely.
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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 Bugs May Cause Wrong Test Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54917-beckman-coulter-dxc-500-au-analyzer-recall-software-bugs-may. Based on FDA recall #Z-2455-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2455-2024%22&limit=1).
The FDA announced on June 5, 2024, that Beckman Coulter Mishima K.K. is recalling 24 DxC 500 AU Clinical Chemistry Analyzers due to software bugs that may cause erroneous patient results. The agency classified the recall as Class II.
GovInfoNow's records show two software bug issues with the analyzer. Issue 1 involves a dedicated rack being used for both patient and calibration orders, causing calibration results to be reported as patient results. Issue 2 involves calibration with expired calibrators. Both may cause erroneous patient results, but the probability of serious adverse health consequences or death is unlikely.
Context
GovInfoNow's records show Beckman Coulter Mishima K.K. has 4 other recalls on record since July 10, 2024. Other recent recalls include the AU480 Chemistry Analyzer recall from Aug. 3, 2026, and the DxC 700 AU Recall from Jan. 30, 2026. Additional similar product recalls include the Beckman Coulter DxC 500i Modules with Software 1.5 Risk on July 15, 2026, and the REMISOL Advance Software Issue on April 29, 2026.
How to tell if you have this one
Check if your DxC 500 AU Clinical Chemistry Analyzer has a serial number listed in the provided range (e.g., 2023070010, 2023060005). The device is for in vitro diagnostic use only and requires specific calibration procedures.
Brand
Beckman Coulter
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Serial Numbers
Verify if your analyzer has a serial number from the list provided in the recall (e.g., 2023070010, 2023060005).
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, and 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 2 months 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-2455-2024 (June 5, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2455-2024 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.