Recall Z-0201-2027— Beckman Coulter, Inc.

Class II FDA medical device recall by Beckman Coulter, Inc., initiated 2026-09-21. FDA's recall record names no specific 510(k) clearance for this event. 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..

Recalling firm

Beckman Coulter, Inc.

Classification

Class II

Status

Ongoing

Initiated

2026-09-21

Firm location

Indianapolis, IN, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.