Quality & complianceOfficial

Dutch inspectorate flags Beckman Coulter SW 40 and SW 41 rotors over fracture risk

🇳🇱 IGJ · Sun 08 Nov 2026

IGJ has published a manufacturer warning after Beckman Coulter rotors used in Optima ultracentrifuges were found with an abnormal microstructure that may cause breakage in use.

The Dutch healthcare inspectorate, IGJ, has published a manufacturer warning on SW 40 and SW 41 rotors used in Beckman Coulter's Optima ultracentrifuges. The notice, dated 9 November 2026 on the IGJ site, says some rotors have been found with an abnormal microstructure.

According to the notice, this defect means certain rotors could break into two or more pieces while in use. The text does not say how many rotors are affected, whether specific serial numbers or lots are involved, or whether any incidents or injuries have been reported.

The manufacturer is Beckman Coulter, Inc., with Beckman Coulter Ireland Inc. named as its authorised representative. The field safety notice (FSN) itself is dated 21 September 2026. The IGJ page links to a two-page PDF of the warning, but the accompanying text gives no details of corrective actions.

IGJ stresses that the item is a warning issued by the manufacturer, not an inspectorate finding. As general context, manufacturers must monitor devices after they reach the market and act where users are at risk. They inform users and the authority through a field safety notice.

What it means for your team

  • Laboratories using Beckman Coulter Optima ultracentrifuges should check whether they hold SW 40 or SW 41 rotors and read the full FSN for instructions.
  • Quality and safety teams should note that the published text does not identify affected batches or serial numbers, so scope must be confirmed from the manufacturer's notice.
  • Regulatory teams should record the FSN date (21 September 2026) and the IGJ publication date (9 November 2026) in their vigilance and field-action tracking.

Official source: IGJ ↗

Article written by VigiEye from the official source (IGJ). AI-assisted; check the source before acting.

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