Product Wiki · Recalls · Health Canada — Medical Devices

Unicel DxC 600i Clinical Analyzer (2017-03-13) — recall 56995

Health Canada — Medical Devices · Canada · 2017-03-31 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
56995
Date of alert
2017-03-31
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Beckman Coulter has confirmed through internal investigation that the access reaction vessel (RV) lots listed fail to meet a specification for outside diameter on the open ended side of the RV. - The RV lots listed may cause aliquot vessel (AV) shuttle motion errors when they are loaded onto the Unicel DXC 600i Synchron Access Clinical System through the closed tube aliquotter (CTA). There is no impact to patient results. - Internal testing did not demonstrate shuttle motion errors on the access 2 standalone system.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/unicel-dxc-600i-clinical-analy

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