DxC AU recallZ-1784-2025 · Beckman Coulter Inc. · initiated Mar 20, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Beckman Coulter Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software design
What the company is doing
On or about 03/20/2025, the firm sent via email or postal mail an Urgent Medical Device Recall letters informing customers that Beckman Coulter has determined that the DxC 500 AU Clinical Chemistry Analyzer may not run a requested calibration order for a two-part reagent and subsequently prevents any new calibration order from being placed. For two-part reagents, when 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. The analyzer will not allow additional calibration orders to be requested for any assays. Customers are instructed to: . Do not place calibration orders when the analyzer is processing samples. . Refer to the DxC 500 AU IFU Reagent Overview section for instructions on Monitoring the Status of Reagents. . Beckman Coulter recommends sharing the content of this letter with their laboratory and/or Medical Director. . If they experience this issue on software version 1.3, 1.4, 1.4.1 or 1.4.2, contact Beckman Coulter for service. . Beckman Coulter recommends posting this Recall Letter on or near the affected systems until the corrections have been made. Resolution: . This has been resolved in software version 1.4.3 in December of 2024. . Your Beckman Coulter service representative will contact you to schedule the software upgrade. For questions - contact Customer Support Center at: . From our website: http://www.beckmancoulter.com . Troubleshooting Hotline: (800) 854-3633
Recall details
- Recall number
- Z-1784-2025
- Status
- Open, Classified
- Initiated by the company
- Mar 20, 2025
- Posted by the FDA
- May 15, 2025
- Recalling firm
- Beckman Coulter Inc.
- Product code
- JJE
- FDA submissions
- K220977
- 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, Malaysia, Netherlands, North Macedonia, Oman, Paraguay, Philippines, Poland, Puerto Rico, Qatar, Saudi Arabia, South Africa, Spain, Switzerland, and Tunisia
Product description
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065. The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.
Code information (models, lots, serial numbers)
Catalog Number: C63519 UDI-DI code: 14987666545058 Serial Numbers: Catalog Number: C63520 UDI-DI code: 14987666545065 Serial Numbers:
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- DxC AU C63520Beckman Coulter, Inc. · Analyzer, Chemistry (Photometric, Discrete), For Clinical Use8 recalls17 reports
- DxC AU C63519Beckman Coulter, Inc. · Analyzer, Chemistry (Photometric, Discrete), For Clinical Use6 recalls0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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