Beckman Coulter Optima Ultracentrifuge Rotors Recalled for Structural Defect
Beckman Coulter is recalling 92 Optima ultracentrifuge rotors that may break during operation, potentially destroying samples and exposing personnel to biohazards.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The source identifies a structural defect that can cause rotor breakage and exposure to biohazardous materials, but the source does not report any illnesses, injuries, or deaths.
Plain-English summary
Beckman Coulter, Inc. is recalling 92 units of the ROTOR ASSY-SW40 (Reference Number 331302) for use in specific Optima XE and XPN ultracentrifuges. The affected rotors may contain a microstructure defect that can cause them to break into two or more pieces during a centrifugation run.
This defect can result in the destruction of samples being processed. When used for in vitro diagnostic (IVD) sample preparation, rotor breakage may delay patient test results. Additionally, the destruction of samples may expose laboratory personnel to biohazardous materials.
The recall covers rotors with serial numbers 24U15260 to 26U15764, distributed nationwide in the United States. Affected centrifuge models include the Optima XPN-100, XPN-90, XPN-80, XE-100, and XE-90.
The recalled product
- 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…
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 92
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Serial Numbers: 24U15260 to 26U15764
- Optima UDI-DI: A99846 - 15099590416324
- A99842 - 15099590415754
- A99839 - 15099590415822
- A99836 - 15099590415846
- A99833 - 15099590415860
Distribution
Distributed nationwide across the United States.
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