Health product recall

XN CHECK BF (2017-12-06)

Starting date:
December 6, 2017
Posting date:
January 12, 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-65662

Affected products

XN CHECK BF

Reason

Sysmex has become aware of an increase in recovery and imprecision of mononuclear cell counts (MN # and MN %) with the XN check BF hematology control lot 7317, level 2.

Affected products

XN CHECK BF

Lot or serial number

7314

Model or catalog number

213516

Companies
Manufacturer

Sysmex Corporation

1-5-1 Wakinohama-kaigandori

Chuo-ku

651-0073

JAPAN