Z-0083-2027

DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU...

Name: Z-0083-2027 DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU...
Creator: Beckman Coulter Inc.
Published: 2026-09-02
License: https://open.fda.gov/license/

Beckman Coulter Inc. / initiated 2026-09-02 / Open, Classified

FDA source

Recall record

Recall number: Z-0083-2027
Status: Open, Classified
Initiated: 2026-09-02
Posted: 2026-10-02
Recalling firm: Beckman Coulter Inc.
Product: DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, DxC 500i, Part No. C63521 3. Access 2 Module, DxC 500i, Part No. C13252
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system default, a subsequent configuration change and activation of the draft configuration in the System Configuration page may cause the analyzer to revert the test units to the system default setting without notifying the user. The system does Pre-Review Reminders Include OII and [email protected] in any discussions on change/elevation of recalls to Class I classification and situations involving additional public communications (FDA and/or firm issued). Post-Review Reminders Final Check: Ensure your documentation accurately reflects the final recommendation prior to signature. Complete CTS: Recall Product tab, Additional Recall Event Info, Regulation, and Act. Upload PDFs of Consult, Review Memo, and Classification Letter for Class I Recall in DocMan. [Click to enter extra reminder]To add reminders, type the reminder in the text field to the left then press the Tab key. Doc ID 03534.05.06 2 of 8 not provide a warning or notification to alert the user that the configured units have reverted to the default units. This issue can result in falsely elevated reported results.
FDA root cause: Software design
Action: On September 2, 2026, the firm began notifying customers via letters titled "URGENT MEDICAL DEVICE RECALL." Customers were instructed to inform their laboratory or medical director to assess laboratory and patient impact. For analyzers on software versions earlier than 1.5: - Users should verify that their instrument displays the intended units in the Test Menu page within the System Configuration page prior to reporting patient results. - Recall letter should be posted on or near affected analyzers if they have the affected software version. This issue is resolved in software version 1.5. If your analyzer is currently operating on an earlier software version, your Beckman Coulter service representative will contact you to schedule the upgrade to software version 1.5.
Quantity in commerce: 146 US, 170 OUS
Distribution: Worldwide - US Nationwide distribution.
Product codes and lots: Software version 1.3.5 or earlier. 1. UDI-DI 14987666545089 2. UDI-DI 14987666545072 3. UDI-DI 15099590742331

Product code JJE

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

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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 2026-10-09. View this recall on fda.gov (opens on fda.gov)