Z-0201-2027

ROTOR ASSY-SW40, Reference Number 331302, when the rotors are installed in the following centrifuges: Optima...

Name: Z-0201-2027 ROTOR ASSY-SW40, Reference Number 331302, when the rotors are installed in the following centrifuges: Optima...
Creator: Beckman Coulter, Inc.
Published: 2026-09-21
License: https://open.fda.gov/license/

Beckman Coulter, Inc. / initiated 2026-09-21 / Open, Classified

FDA source

Recall record

Recall number: Z-0201-2027
Status: Open, Classified
Initiated: 2026-09-21
Posted: 2026-10-21
Recalling firm: Beckman Coulter, Inc.
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)
Product code: JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
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 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 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.
Product codes and lots: Serial Numbers: 24U15260 to 26U15764; Optima UDI-DI: A99846 - 15099590416324, A99842 - 15099590415754, A99839 - 15099590415822, A99836 - 15099590415846, A99833 - 15099590415860

Product code JQC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-10-23. View this recall on fda.gov (opens on fda.gov)