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
Affected Products
- Benchmark Ultra Automated Immunostaining System
- 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
A. Benchmark Ultra Automated Immunostaining System
Lot or serial number
- More than 10 numbers, contact manufacturer.
Model or catalog number
- N750-BMKU-FS
Companies
- Manufacturer
-
Ventana Medical Systems Inc.
1910 E Innovation Park Drive,
Tucson
85755
Arizona
UNITED STATES
B. Benchmark XT
Lot or serial number
- More than 10 numbers, contact manufacturer.
Model or catalog number
- N750-BMKXT-FS
Companies
- Manufacturer
-
Ventana Medical Systems Inc.
1910 E Innovation Park Drive,
Tucson
85755
Arizona
UNITED STATES