Recall Z-0201-2027 ยท JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Beckman Coulter, Inc.
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)
| Date | Oct 21, 2026 (initiated Sep 21, 2026) |
| Status | Open, Classified |
| 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 |
| 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 | 92 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.