# Class II recall Z-0083-2027: Beckman Coulter Inc.

**Predicate Speed & CAPA Advisory Opportunity Score:** 62/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0083-2027 |
| Recalling firm | Beckman Coulter Inc. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| 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 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 sign |
| Quantity | 146 US, 170 OUS |
| Distribution | Worldwide - US Nationwide distribution. |
| Recall initiated | 2026-09-02 |
| Reported | 2026-10-14 |
| Firm location | Brea, CA, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 22 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0083-2027%22). Last refreshed: 2026-11-04T21:30:53.898Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.