Beckman Coulter Centrifuge Rotors Recalled for Structural Defect
Beckman Coulter is recalling 336 SW41 rotors for Optima centrifuges due to a non-conforming microstructure that may cause the rotors to break during use.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as Class II by the FDA. The source describes a hazard where rotors may break into multiple pieces, causing significant damage to samples and the instrument, but the source does not report any illnesses, injuries, or deaths.
Plain-English summary
Beckman Coulter, Inc. is recalling 336 units of ROTOR ASSY-SW41 (Reference Number 331362) installed in specific Optima centrifuges. The affected models include the Optima XPN-100, XPN-90, XPN-80, XE-100, and XE-90. The rotors were distributed nationwide in the United States.
The recall is due to a non-conforming microstructure in the rotors, which may result in some rotors breaking into two or more pieces during use. Rotors that break into multiple pieces during use may result in significant damage to materials (i.e., samples) being processed in the centrifuge and to the centrifuge instrument.
The source text does not provide specific instructions for consumers or end-users on how to stop using the product or how to obtain a remedy. Users of the affected centrifuges should contact Beckman Coulter for further instructions.
The recalled product
- Product
- ROTOR ASSY-SW41, Reference Number 331362, 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
- 336
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: 24U15250 to 26U15766
- Optima UDI-DI: A99846 - 15099590416324
- A99842 - 15099590415754
- A99839 - 15099590415822
- A99836 - 15099590415846
- A99833 - 15099590415860
Distribution
Distributed nationwide across the United States.
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