Product Wiki · Recalls · Health Canada — Medical Devices

AQUIOS LYSE REAGENT KIT — recall 55753

Health Canada — Medical Devices · Canada · 2016-11-03 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
55753
Date of alert
2016-11-03
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: The use of AQUIOS Lysing Reagent Kit (lot numbers 6040014K and 6040015K) may lead to an increased generation of notifications and flags when used on the AQUIOS CL Flow Cytometer when running the AQUIOS Tetra Application. The issue could lead to an increase in the number of samples requiring review and re-runs with a potential delay to the reporting of results. Depending on the specimen age, a new blood specimen may be required.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/aquios-lyse-reagent-kit

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