Beckman Coulter, Inc. recalls ROTOR ASSY-SW40
- Recalling company
- 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)
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Sep 21, 2026
- Reported
- Oct 28, 2026
- Distribution
- US Nationwide distribution.
- Status
- Ongoing
- Quantity
- 92 units
- Lot / codes
- Serial Numbers: 24U15260 to 26U15764; Optima UDI-DI: A99846 - 15099590416324, A99842 - 15099590415754, A99839 - 15099590415822, A99836 - 15099590415846, A99833 - 15099590415860
- Company location
- Indianapolis, IN
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0201-2027
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0201-2027 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.