AQUIOS CL FLOW CYTOMETRY SYSTEM (2017-10-02)

Starting date:

October 2, 2017

Posting date:

November 28, 2017

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

Healthcare Professionals, General Public, Hospitals

Identification number:

RA-65244

• Reason
• Affected products

Affected products

AQUIOS CL FLOW CYTOMETRY SYSTEM

Reason

When AQUIOS CL Systems are connected to a Laboratory Information System (LIS), the system may duplicate sample requests leading to sample mis-identification. For this to happen, the following conditions must be met:

• The AQUIOS CL Flow Cytometer is connected to an LIS and
• The AQUIOS CL System has the default test enabled and
• Host query is enabled in LIS setup screen on system and
• There are multiple cassettes in the autoloader and
• The LIS host query response is received in a brief time window before LIS response timeout occurs.

When all of these conditions are met, a sample will follow two (2) paths of test request creation (LIS and Default Test).

All software versions (2.0, 2.0.1 and 2.1) in existence are impacted by this issue and all applications used on the AQUIOS CL are impacted by this issue.

Affected products