Reported Oct 28, 2026 · Ongoing · Updated Nov 2, 2026
ROTOR ASSY-SW40, Reference Number 331302, when the rotors are installed in the following centrifuges: Optima XPN-100…
Beckman Coulter, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter, Inc. · 5355 W 76th St · Indianapolis, IN · 46268-4166
Is this the product you have?
ROTOR ASSY-SW40Reference Number 331302when the rotors are
- installed in the following centrifugesOptima 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)
- Lot codes and dates
- Serial Numbers24U15260 to 26U15764
- Optima UDI-DI
A99846 - 15099590416324A99842 - 15099590415754A99839 - 15099590415822A99836 - 15099590415846A99833 - 15099590415860
- Amount recalled
- 92 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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