Recall Z-0202-2027 ยท JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Beckman Coulter, Inc.
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)
| Date | Oct 21, 2026 (initiated Sep 21, 2026) |
| Status | Open, Classified |
| 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 |
| Action | An URGENT MEDICAL DEVICE RECALL notification letter dated 9/9/26 was sent to customers. Return the completed customer response form to Beckman Coulter. Upon receipt of your form, we will coordinate a replacement of your rotor(s). If you have another compatible rotor available that is not included in the Serial Numbers listed above, discontinue use of the affected rotor(s) and use the alternative rotor until your replacement rotor is received. A description of the compatible rotors is available in the instrument instructions for use. If no alternative compatible rotor is available and continue |
| Quantity | 336 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.