ORTHO VISION ANALYZER (2020-12-22)

Starting date:

December 22, 2020

Posting date:

January 7, 2021

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-74707

Last updated:
2021-01-07

• 
  Reason
• 
  Affected products

Affected Products 

A. ORTHO VISION ANALYZER

B. ORTHO VISION MAX ANALYZER

Reason

Due to a software anomaly on Ortho Vision and Ortho Vision Max Analyzers configured with software version 5.12.8 Or 5.13.0, flushing of the pipette may occur in a reagent vial after the Pipette Arm (PIPA) exits idle mode, one or more reagent/diluent vials are loaded on the system and the operator enters maintenance mode before the analyzer completes the reagents inventory.

Affected products