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Health product recall

XN-L Series

Starting date:
August 11, 2017
Posting date:
September 8, 2017
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-64460

Reason

This correction alerts the customers to a software problem that causes possible false low WBC counts when using the low WBC mode. Three other software anomalies related to abnormal sample flagging were also identified in this software version.

Affected products

XN-L Series

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

  1. XN-450
  2. XN-550

Companies

Manufacturer
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku
651-0073
JAPAN