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Benchmark Ultra Automated Immunostaining System & Benchmark XT… — recall 61233

Health Canada — Medical Devices · Canada · 2020-05-08 · Type III

As described by Health Canada — Medical Devices: Benchmark Ultra Automated Immunostaining System & Benchmark XT (2020-04-08)

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Agency
Health Canada — Medical Devices
Recall identifier
61233
Date of alert
2020-05-08
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Following the information provided by our manufacturer on investigation of customer complaints, we would like to inform you of an issue that has been identified in Ventana software system (VSS V 11.0 to 12.5.3 when used with identified staining instruments) that can result in the software allowing a dispenser to be used beyond their intended capacity when a slide is aborted/stopped while the SW is in compiling or starting state. The manufacturer advised us of this on 06-Apr-2020.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/benchmark-ultra-automated-immu

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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