Benchmark Ultra Automated Immunostaining System & Benchmark XT (2020-04-08)

Starting date:

April 8, 2020

Posting date:

May 8, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-73029

Last updated: 2020-05-08

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  Reason
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  Affected products

Affected Products

1. Benchmark Ultra Automated Immunostaining System
2. Benchmark XT

Reason

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.

Affected products