# Class II recall Z-0201-2027: Beckman Coulter, Inc.

**Predicate Speed & CAPA Advisory Opportunity Score:** 68/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0201-2027 |
| Recalling firm | Beckman Coulter, Inc. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | ROTOR ASSY-SW40, Reference Number 331302, when the rotors are installed in the following centrifuges: Optima XPN-100 (Model Numbers A99846 and A94469), Optima XPN-90 (Model Numbers A99842 and A94468), Optima XPN-80 (Model Numbers A99839 and A95765), Optima XE-100 (Model Numbers A99836 and A94516), and Optima XE-90 (Model Numbers A99833 and A94471) |
| Reason | Optima XE XPN ultracentrifuge rotors may contain a microstructure defect that can cause rotors to break into two or more pieces (bifurcate) during a centrifugation run, resulting in destruction of samples being processed. When used for in vitro diagnostic (IVD) sample preparation, rotor breakage may delay patient test results. Additionally, sample destruction may expose laboratory personnel to biohazardous materials. |
| Quantity | 92 units |
| Distribution | US Nationwide distribution. |
| Recall initiated | 2026-09-21 |
| Reported | 2026-10-28 |
| Firm location | Indianapolis, IN, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 8 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-0201-2027%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.