Device recall
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)
- Recall number
- Z-0201-2027
- 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
- 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.
- Root cause
- Nonconforming Material/Component
- Quantity
- 92 units
- Code info
- Serial Numbers: 24U15260 to 26U15764; 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