Product Wiki · Recalls · Health Canada — Medical Devices

AQUIOS IMMUNO-TROL Low Cells (2019-07-01) — recall 59993

Health Canada — Medical Devices · Canada · 2019-07-19 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
59993
Date of alert
2019-07-19
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/aquios-immuno-trol-low-cells-2

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