Health product recall

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

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

AQUIOS IMMUNO-TROL Low Cells

Lot or serial number

6180091 (6180091K)

Model or catalog number

B25700

Companies
Manufacturer

Beckman Coulter Diagnostics Limited

Lismeehan
O'Callaghans Mills

Co. Clare

IRELAND
Tel: +353 (0) 65 683 1100
Fax: +353 (0) 65 683 1122