Navios Color Lasers (2013-05-30)

Starting date:

May 30, 2013

Posting date:

October 16, 2013

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-36053

• 
  Reason
• 
  Affected products

Recalled Products

A. Navios 6 Colors / 2 Lasers 

B. Navios 8 Colours / 2 Lasers

C. Navios 10 Colours / 3 Lasers

Reason

Beckman Coulter has identified that the fluorescence photo-multiplier tube (PMT) gain settings displayed in the cytometer control dialog box may not reflect the actual PMTgain settings on the Navios flow cytometer. If a change to the fluorescence gain is made at any time to any protocol and saved (or not saved), all susequently loaded protocols will apply the previously set gain parameters regardless of what the cytometer control dialog is showing. Therefore, any subsequent protocol may not reflect the actual system gain in the cytometer control dialog box.

Affected products