System DI-60 Main Unit and Remote Review Software (2018-01-23)

Starting date:

January 23, 2018

Posting date:

February 1, 2018

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-65888

• 
  Reason
• 
  Affected products

Affected products

1. System DI-60 Main Unit
2. System DI-60 Remote Review Software

Reason

Sysmex America, Inc. has been made aware of a software defect on versions 6.0.1 and 6.0.2 running on the CellaVision DM-series and Sysmex DI-60 that may cause comments to not be transmitted to the Laboratory Information System (LIS). If all the following three conditions are met, the comments will not be transmitted from the CellaVision Software to the LIS:

1. The analyzer system computer, server and remote review software installed is on version 6.0.1 or 6.0.2
2. The workflow with multiple slides for blood samples is used
3. WBC (White Blood Cell), RBC (Red Blood Cell) and PLT (Platelets) comments are added to the last slide after it has been already signed

Affected products