—#215487

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

FDA product code: CGR — Radioimmunoassay, Cortisol
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K242190
Affected lot / code info: REF/UDI-DI: C63522/14987666545089, C63521/14987666545072. Software Versions: SW 1.3.3 and 1.3.4

Why it was recalled

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 (FDA determination)

Software Design Change

Action the firm took

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: regaffairsfax@beckman.com 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

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2025-08-04
Posted by FDA: 2025-10-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #215487. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.