Beckman Coulter Inc. recalls DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE
- Recalling company
- 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
- Reason
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Sep 2, 2026
- Reported
- Oct 14, 2026
- Distribution
- Worldwide - US Nationwide distribution.
- Status
- Ongoing
- Quantity
- 146 US, 170 OUS
- Lot / codes
- Software version 1.3.5 or earlier. 1. UDI-DI 14987666545089 2. UDI-DI 14987666545072 3. UDI-DI 15099590742331
- Company location
- Brea, CA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0083-2027
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0083-2027 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.