Class 2 Device Recall Optima XE XPN centrifuges

• Date Initiated by Firm: September 21, 2026
• Date Posted: October 21, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0201-2027
• Recall Event ID: 99882
• Product Classification: Centrifuges (micro, ultra, refrigerated) for clinical use - Product Code JQC
• Product: 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)
• Code Information: Serial Numbers: 24U15260 to 26U15764; Optima UDI-DI: A99846 - 15099590416324, A99842 - 15099590415754, A99839 - 15099590415822, A99836 - 15099590415846, A99833 - 15099590415860
• FEI Number: 3007448124
• Recalling Firm/ Manufacturer: Beckman Coulter, Inc.; 5355 W 76th St; Indianapolis IN 46268-4166
• For Additional Information Contact: Kristin Godfredsen; 760-419-7078
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 continued use is necessary, you may continue to use your current rotor until you receive a replacement rotor; however, continued use carries a possibility of rotor breakage which may result in significant damage to materials (i.e., samples) being run in the centrifuge and the centrifuge instrument. Should you experience rotor breakage, please contact your service representative. Use personal protective equipment, and standard laboratory operating procedures for the handling of biohazardous materials when opening the centrifuge to prevent exposure to damaged materials (i.e., samples). Once your completed response form is received, a Beckman Coulter representative will coordinate a free-of-charge replacement order for you. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them a copy of this letter. So that we are assured you have received this important communication, please respond within 10 days in one of the following ways: " Electronically, if you received this communication via electronic system. " Manually, complete and return the enclosed Response Form. If you have any questions regarding this notice, please contact Customer Support Center. "From our website: http://www.beckman.com "By
• Quantity in Commerce: 92 units
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.