Health product recall

Sysmex XN-10 Hematology Analyzer (2019-01-14)

Starting date:
January 14, 2019
Posting date:
January 31, 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, Healthcare Professionals, Hospitals
Identification number:
RA-68962

Affected Products

Sysmex XN-10 Hematology Analyzer

Reason

Sysmex has identified a defect in the shielding used for the flow cytometry module (FCM) detector wiring harness in certain XN-10 analyzers. Improper shielding of the FCM detector may result in abnormal scattergram patterns and increased flagging. Numeric results are not affected.

Affected products

Sysmex XN-10 Hematology Analyzer

Lot or serial number

35739

36053

14166

Model or catalog number

XN-10

Companies
Manufacturer

Sysmex Corporation

1-5-1 Wakinohama-kaigandori

Chuo-ku

651-0073

JAPAN