Navios Flow Cytometry Software (two different models)

Starting date:

October 24, 2011

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-15109

• Reason
• Affected products

Reason

When running a Multi-tube Worklist, there is a slight possibility that a Listmode file may be duplicated. When this happens, the next tube on the worklist is skipped (not sampled). Subsequent tubes on the worklist are processed correctly. The duplicated listmode file contains all of the correct data events and FCS keyword information but will have the skipped tube's Listmode filename assigned to it. Therefore any panel report generated from the skipped tube may have erroneous but credible results.

Affected products