XN-L CHECK (2019-07-09)

Starting date:

July 9, 2019

Posting date:

August 2, 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, Hospitals, Healthcare Professionals

Identification number:

RA-70575

Last updated: 2019-08-02

• 
  Reason
• 
  Affected products

Affected Products

XN-L CHECK

Reason

Sysmex America, Inc. (Sai) recognized a trend with complaints from XN-L-series customers reporting low recovery of the Red Blood Cell Distribution Width  (RDW) RDWCV and RDW-SD parameters on one or more of the three levels of the XN-L check hematology control lot 9158

Affected products