Device recall
DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE, Part No. C63520
- Recall number
- Z-0084-2027
- Event id
- 99800
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Beckman Coulter Inc.
- Report date
- Oct 14, 2026
- Posted
- Oct 2, 2026
- Initiated
- Sep 2, 2026
- Center classification date
- Oct 2, 2026
- Product code
- JJE
- Device type
- Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Reason
- Beckman Coulter has identified a software issue affecting DxC 500 AU 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 CDRHRecallGroup@fda.hhs.gov 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.
- Root cause
- Software design
- Quantity
- 146 US, 170 OUS
- Code info
- Software version 1.4.5 or earlier. 1. UDI-DI 14987666545058 2. UDI-DI 14987666545065
- Distribution
- Worldwide - US Nationwide distribution.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K220977
- Location
- Brea, CA, United States