DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module recallZ-0083-2027 · Beckman Coulter Inc. · initiated Sep 2, 2026

Why it was recalled

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 category: Software design

What the company is doing

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.

Recall details

Recall number

Z-0083-2027

Status

Open, Classified

Initiated by the company

Sep 2, 2026

Posted by the FDA

Oct 2, 2026

Recalling firm

Beckman Coulter Inc.

Quantity

146 US, 170 OUS

Product code

JJE

FDA submissions

K242190

Distribution

Worldwide - US Nationwide distribution.

Product description

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

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

• DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module C63522

  Beckman Coulter, Inc. · Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
  4 recalls5 reports
• DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module C63521

  Beckman Coulter, Inc. · Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
  4 recalls0 reports
• DxC 500i Clinical Analyzer, DxC 500i Access 2 Immunoassay Module C13252

  Beckman Coulter, Inc. · Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
  3 recalls3 reports

Product lines

• DxC 500i Clinical Analyzer, DxC 500i AU Chemistry ModuleBeckman Coulter, Inc. · 2 models · 5 reports · 4 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 99800).

• Z-0084-2027 · Open, Classified
  DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE, Part No. C63520