Beckman Coulter Optima ultracentrifuge rotors recalled for breakage risk
What this means
Beckman Coulter has recalled certain SW40 rotors (Reference 331302) used in Optima XE and XPN ultracentrifuges due to a defect that can cause rotors to break during operation. Rotor breakage destroys samples being processed and can expose laboratory workers to biohazardous materials. When used for patient testing, breakage may delay diagnostic results.
- Check if your Optima XE or XPN centrifuge uses a SW40 rotor with serial numbers 24U15260 to 26U15764.
- Stop using affected rotors immediately and contact Beckman Coulter for a replacement or remedy.
- Do not operate the centrifuge with a recalled rotor.
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0201-2027More Beckman Coulter recalls
- FDA-Device2026-10-21Beckman Coulter SW41 rotor assembly recalled for breakage risk in Optima centrifuges
- FDA-Device2026-10-21Beckman Coulter IQ200 laboratory analyzers recalled for fluid leakage risk
- FDA-Device2026-10-21Beckman Coulter DxU 840m and 850m Iris analyzers recalled for lamina fluid leakage risk
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