Z-1784-2025Class II

DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 /...

Name: Z-1784-2025 DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 /...
Creator: Beckman Coulter Inc.
Published: 2025-03-20
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2025-03-20 / Open, Classified / root cause: software

FDA source

Beckman Coulter Inc. began a recall of DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065. The Beckman Coulter DxC 500 AU Clinical... on 2025-03-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1784-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-20
Posted: 2025-05-15
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: 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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for 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.
Root cause tag: software
FDA root cause: Software design
Action: 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
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 codes and lots: Catalog Number: C63519 UDI-DI code: 14987666545058 Serial Numbers: Catalog Number: C63520 UDI-DI code: 14987666545065 Serial Numbers:

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1784-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1784-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-21	2025-05-15

Product code JJE

K220977Class IIISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerBeckman Coulter Laboratory Systems (Suzhou) Co., Ltd. / cleared 2023-07-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)