ROTOR ASSY-SW40, Reference Number 331302, when the rotors are installed in the following centrifuges: Optima XPN-100 (Mo
Summary
The FDA issued a Class II for ROTOR ASSY-SW40, Reference Number 331302, when the rotors are installed in the f by Beckman Coulter, Inc.. 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 c.
Details
Source
Device Recall
External ID
Z-0201-2027
Action Date
2026-10-28
Status
Ongoing
Category
device
Product Description
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)
Lot/Code Info: Serial Numbers: 24U15260 to 26U15764; Optima UDI-DI: A99846 - 15099590416324, A99842 - 15099590415754, A99839 - 15099590415822, A99836 - 15099590415846, A99833 - 15099590415860
Quantity Affected: 92 units
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.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-09-21
Company
Indianapolis, IN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 187 device recalls issued in the same week, part of 480 device-related FDA actions this month.
Beckman Coulter, Inc. has 155 FDA actions in our database, including 111 recalls and 44 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Beckman Coulter, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Beckman Coulter, Inc. have FDA actions?
Beckman Coulter, Inc. has 155 FDA actions in our database, including 111 recalls and 44 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0201-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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