Lower risk Medical device recall · FDA · Published March 20, 2025

Beckman Coulter DxC 500 AU Analyzer Recall: Software Error Causes Calibration Delays

Beckman Coulter recalls DxC 500 AU Clinical Chemistry Analyzers with specific catalog numbers due to a software error that prevents calibration orders from completing, potentially delaying test results.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1784-2025Medical device Beckman Coulter ›

Lower-risk recall

Beckman Coulter is recalling their DxC 500 AU Clinical Chemistry Analyzer because a software error causes the analyzer to not run a requested calibration order in the following scenario: when a reagent blank or calibration is ordered during sample processing and then any of the components (R1 and/or R2) depletes to zero tests, the analyzer will not be able to complete the calibration request, and the calibration order will remain pending. No further calibration orders can be processed for any assays, and the instrument refuses to accept further sample processing order after the existing calibration curves are expired. Although in-process tests will be completed, this error can cause a delay in reporting subsequent test results. No further calibration orders can be processed for any assays which may cause a delay in reporting test results.

Take action

Contact the company

Recalling firmBeckman Coulter Inc.250 S Kraemer Blvd · Brea, CA 92821-6232

✎ GovInfoNow plain-language explainer

Beckman Coulter is recalling DxC 500 AU Clinical Chemistry Analyzers with specific catalog numbers because a software error can cause calibration orders to remain pending, delaying test results. This affects labs using the equipment for in vitro diagnostics. Read more at govinfonow.com/recall/52589-beckman-coulter-dxc-500-au-analyzer-recall-software-error-causes.

Source Summary by GovInfoNow · govinfonow.com/recall/52589-beckman-coulter-dxc-500-au-analyzer-recall-software-error-causes · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1784-2025

Cite this page

“Beckman Coulter DxC 500 AU Analyzer Recall: Software Error Causes Calibration Delays.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52589-beckman-coulter-dxc-500-au-analyzer-recall-software-error-causes. Based on FDA recall #Z-1784-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1784-2025%22&limit=1).

The FDA announced on March 20, 2025, that Beckman Coulter Inc. is recalling its DxC 500 AU Clinical Chemistry Analyzers due to a software error that prevents calibration orders from completing. This issue may cause delays in reporting subsequent test results for users of the affected devices.

How to tell if you have it

Brand: Beckman Coulter
Product: DxC 500 AU Clinical Chemistry Analyzer
Catalog Numbers/UDI codes: C63519 / 14987666545058 and C63520 / 14987666545065

The hazard

According to the FDA, a software error causes the analyzer to not run a requested calibration order when a reagent blank or calibration is ordered during sample processing and components deplete. This prevents further calibration orders from being processed for any assays and may cause a delay in reporting subsequent test results.

Context

GovInfoNow's records show Beckman Coulter, Inc. has had 132 other recalls on record since June 20, 2017. Other recent recalls of similar products include Beckman Coulter DxC 500 AU Modules with Software 1.5 Risk Patient Test Errors (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). Additional similar recalls include Beckman Coulter AU5800 Chemistry Analyzer Recall (Jan. 30, 2026), Beckman Coulter DxC 700 AU Recall (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 catalog numbers C63519 or C63520 on the analyzer. The UDI codes 14987666545058 and 14987666545065 are also associated with these models.

Brand
Beckman Coulter
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check for Pending Calibration Orders
Review the analyzer's calibration status to identify pending orders that may need resolution.

Where it went and when

Where it was distributed

Distributed in 16 states and Puerto Rico, and outside the U.S.

FDA distribution: “U.S: AL, CA, GA, ID, IN, LA, MA, MI, MN, MT, NC, NV, PA, PR, TN , TX, and WI O.U.S.: Australia, Belgium, Bosnia and Herzegovina, Canada, Chile, Croatia, Egypt, Ethiopia, France, Germany, Ghana, India, Italy, Korea, Lebanon, Libya,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, California, Georgia, Idaho, Indiana, Louisiana, Massachusetts, Michigan, Minnesota, Montana, Nevada, North Carolina, Pennsylvania, Puerto Rico, Tennessee, Texas, Wisconsin.

Recall timeline

FDA published this recall 2 months after the firm started it.

Mar 20, 2025Firm started the recall
May 15, 2025FDA classified it Class II
May 21, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/52589-beckman-coulter-dxc-500-au-analyzer-recall-software-error-causes">Beckman Coulter DxC 500 AU Analyzer Recall: Software Error Causes Calibration Delays (GovInfoNow)</a>

Where this comes from

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-1784-2025 (March 20, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1784-2025 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.