XN CHECK (2018-01-04)

Starting date:

January 4, 2018

Posting date:

January 29, 2018

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-65782

• 
  Reason
• 
  Affected products

Affected products

XN CHECK

Reason

Sysmex has become aware of an increase in imprecision of lymphocyte (lym #, lym %) and Monocyte (Mono #, Mono %) counts with the XN Check hematology control. All other parameters on the assay sheet are not affected. Patient results are also unaffected.

Affected products