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