Device recall
ROTOR ASSY-SW41, Reference Number 331362, 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)
- Recall number
- Z-0202-2027
- Event id
- 99882
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Beckman Coulter, Inc.
- Report date
- Oct 28, 2026
- Posted
- Oct 21, 2026
- Initiated
- Sep 21, 2026
- Center classification date
- Oct 21, 2026
- Product code
- JQC
- Device type
- Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- Reason
- Rotors have been found with a non-conforming microstructure, which may result in some rotors breaking into two or more pieces during use. Rotors that break into multiple pieces during use may result in significant damage to materials (i.e., samples) being processed in the centrifuge and to the centrifuge instrument.
- Root cause
- Nonconforming Material/Component
- Quantity
- 336 units
- Code info
- Serial Numbers: 24U15250 to 26U15766; Optima UDI-DI: A99846 - 15099590416324, A99842 - 15099590415754, A99839 - 15099590415822, A99836 - 15099590415846, A99833 - 15099590415860
- Distribution
- US Nationwide distribution.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Indianapolis, IN, United States