AQUIOS LYSE REAGENT KIT

Starting date:

October 17, 2016

Posting date:

November 3, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-60810

• Reason
• Affected products

Affected Products

Reason

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.

Affected products