Z-0032-2026Class II

DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF...

Name: Z-0032-2026 DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF...
Creator: Beckman Coulter Inc.
Published: 2025-08-04
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2025-08-04 / Open, Classified / root cause: software

FDA source

Beckman Coulter Inc. began a recall of DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i Clinical Analyzer on 2025-08-04. FDA classified it as Class II and gives the reason as "On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed between the CC tests, CC sample status will remain In Progress...". 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-0032-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-04
Posted: 2025-10-02
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i Clinical Analyzer
Product code: CGR Radioimmunoassay, Cortisol
Reason for recall: On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed between the CC tests, CC sample status will remain In Progress with no errors, may cause processing delays.
Root cause tag: software
FDA root cause: Software Design Change
Action: On 8/4/2025, recall notices were mailed and/or emailed to customers who were asked to do the following: Check your software version, select Menu - About page. - For Clinical Analyzers running software version 1.3.3 or 1.3.4, if this issue occurs, you will need to place a new order for the CC combination test, - Select Home - Sample List task indicator, then select Active in the upper left corner of the Sample List to display samples "In Progress". - Program the CC combination tests for these "In Progress" samples using a new rack and Sample ID, apply the new barcode, then load the rack onto the analyzer for processing. - Set aside the rack with "In Progress" samples and contact your Beckman Coulter representative to clear them. Firm recommends sharing the content of this letter with your laboratory and/or Medical Director. Firm has resolved this issue in Software version 1.3.5 and a firm service representative will contact you to schedule the software upgrade. Share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them a copy of this letter. Complete and return the response form via email to: [email protected] If you have any questions regarding this product, please contact your local firm representative, or use the following link for a listing of local contact information. https://www.beckmancoulter.com/en/support/contact-us
Quantity in commerce: 116
Distribution: Internationally distribution to the countries of Poland, India, Dominican Republic, Lebanon, Italy, Brazil, El Salvador, Saudi Arabia, Germany, France, Nepal, Canada, Chile, Spain, Malaysia, Switzerland, Morocco, Philippines, Curacao, Qatar, United Arab Emirates, Hungary, Czechia, Oman, New Zealand, Thailand, Indonesia, Algeria, United Kingdom of Great Britain and Northern Ireland, Namibia, Turkey, Republic of Korea
Product codes and lots: REF/UDI-DI: C63522/14987666545089, C63521/14987666545072. Software Versions: SW 1.3.3 and 1.3.4

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0032-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0032-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-08	2025-10-02

Product code CGR

K242190Class IIAccess Cortisol; DxC 500i Clinical AnalyzerBeckman Coulter, Inc. / cleared 2025-03-05

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)