FDA-Device2026-10-21Class IIPROCESSING DEFECT

Beckman Coulter SW41 rotor assembly recalled for breakage risk in Optima centrifuges

OTHERNationwide distributionMedical devices

What this means

Beckman Coulter discovered that some SW41 rotor assemblies (Reference 331362) have a structural defect that may cause them to break into multiple pieces during centrifuge operation. This can damage samples and the centrifuge instrument itself. The affected rotors were installed in five Optima centrifuge models.

  • If you operate an Optima XPN-100, XPN-90, XPN-80, XE-100, or XE-90 centrifuge with serial numbers 24U15250 to 26U15766, stop using the SW41 rotor immediately.
  • Contact Beckman Coulter for a replacement rotor and inspection of your centrifuge.
  • Check your rotor's serial number against the affected range before resuming use.
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The agency's original wording
Hazard

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.

Intended for
All ages
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
336 units
Manufactured in
5355 W 76th St, Indianapolis, Indiana, United States
Products
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)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0202-2027

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