AQUIOS IMMUNO-TROL Low Cells (2019-07-01)

Starting date:

July 1, 2019

Posting date:

July 19, 2019

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-70451

Last updated: 2019-07-19

• Reason
• Affected products

Affected Products

AQUIOS IMMUNO-TROL Low Cells

Reason

Some Beckman Coulter customers have reported quality control (QC) failure on the AQUIOS system when performing testing with the affected lot. Beckman Coulter has confirmed through internal testing of this product lot that the system may include a significant portion of the monocyte population in the lymphocyte region during automated data analysis due to insufficient separation of the two populations in the side scatter vs. CD45 plot.

Affected products